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Customer Information Bulletins

Key updates and information about our products:

 •  Product changes that may affect users or patients

 •  Updated recommendations, guidelines or user warnings

  • Details of product recalls

  • Updated regulatory documentation

 

Date published

Download
document

Bulletin details

18/03/2024

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Rocket Medical® Spinal Manometer – R55990-ISO-6

All batches going forward, will now revert back to the stopcock being supplied in the open position.

12/03/2024

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Manufacturing Unit of Issue

From 1st January 2024 under MDR and 510k requirements Rocket Medical will only supply devices in their Manufacturing Unit of Issue.

08/02/2024

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Haemorrhoidal Injection Sets

Following a review of our Colorectal Product Range, we have taken the decision to discontinue the Haemorrhoidal Injection Sets, Product Codes R56210 and R56211.

11/01/2024

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Rocket Medical® Thoracentesis Kits

The supplier of the drainage bag used in the Thoracentesis Kits has withdrawn supply.

11/01/2024

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Rocket Medical® IPC Drainage Kits UK

The supplier of the drainage bag used in the IPC Drainage Kits has withdrawn supply.

11/01/2024

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Rocket Medical® IPC Drainage Kits USA

The supplier of the drainage bag used in the IPC Drainage Kits has withdrawn supply.

11/01/2024

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Rocket Medical® IPC Drainage Kits ROW

The supplier of the drainage bag used in the IPC Drainage Kits has withdrawn supply..

11/01/2024

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Rocket Medical® Thoracentesis Catheters and Spinal Manometers

The 3-way tap on the following products is changing.

13/12/2023

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FBS Kit for Handheld Lactate Analysers

We are introducing two changes to R57028-00-SW, FBS Kit for Handheld Lactate Analysers.

13/12/2023

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Rocket Medical® R54569 PSU Software Update

A new software update for the R54569 Portable Suction Unit has been published.

11/12/2023

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Rocket Medical® R54569 PSU Software Update

A new software update for the R54569 Portable Suction Unit has been published.

22/08/2023

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Rocket Medical® Verres Needles

Following a review of our Operating Theatre products, we have taken the decision to discontinue all Verres style needles from our product portfolio.

22/08/2023

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Rocket Medical Rectal Solution Set

We have made the decision to discontinue the Rocket Medical Rectal Solution Set, Product Code R56215-M, from our colorectal range.

20/06/2023

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Temporary Supply Issue for Rocket Medical® Pleural Vent (R54565)

The Rocket Medical Pleural Vent is currently unavailable due to a manufacturing supply issue.

20/06/2023

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Discontinuation of Uterine Sound

Following a recent review, we have made the decision to discontinue the Rocket Medical Uterine Sound, Product Code R57420, from our gynaecology range.

20/06/2023

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Discontinuation of Amniotomy Hook

Following a recent review, we have made the decision to discontinue the Rocket Medical Amniotomy Hook, Product Code R57065, from our obstetrics range.

11/05/2023

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Temporary removal of ZDLTR038 or ZDLTR045 to ZDLTR037 USA in IPC insertion Sets

Due to supply chain issues we are having to remove the current short Tearaway sheath dilator for the foreseeable future.

25/04/2023

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Embryon® Embryo Transfer and Trial Catheters

Due to a supplier issue, we will permanently change the colour of the marker bead on the Embryon® Genesis™, Embryon® EchoCath™ and Embryon® BulbTip™ Embryo Transfer and Trial Catheters.

04/04/2023

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Rocket Medical IPC Insertion Kits

Due to supply chain issues we are having to replace the current short Tearaway sheath dilator with a standardlength version for the foreseeable future.

23/12/2022

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UK - Rocket Medical Fetal Scalp Electrode

Rocket Medical is endeavouring to support as many customers as possible, but with the sudden increase in product demand, we are not able to fulfil all orders. Rocket Medical is taking steps to increase manufacturing capacity as quickly as possible

23/12/2022

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USA - Rocket Medical Fetal Scalp Electrode

Rocket Medical is endeavouring to support as many customers as possible, but with the sudden increase in product demand, we are not able to fulfil all orders. Rocket Medical is taking steps to increase manufacturing capacity as quickly as possible

23/12/2022

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AUS - Rocket Medical Fetal Scalp Electrode

Rocket Medical is endeavouring to support as many customers as possible, but with the sudden increase in product demand, we are not able to fulfil all orders. Rocket Medical is taking steps to increase manufacturing capacity as quickly as possible

28/09/2022

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Rocket Medical® Introducer Needles

Following a review of our Ascites Drainage products, we have taken the decision to discontinue all Introducer Needles from our portfolio.

28/09/2022

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Rocket Medical® Thoracic Catheters

We are having to consolidate our range of Thoracic Catheters and as a result, the decision has been made to halt production of the codes below.

22/09/2022

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Rocket Medical® Ambulatory bag

Due to ongoing supply chain issues, you may receive the Rocket Medical® R54564 Ambulatory Bag without an activated carbon filter.

20/09/2022

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Change to R57016-PLUS-NS

Due to component availability, we have made the decision to remove the forceps from product code R57016-PLUS-NS - the long (200mm) version of our fetal blood sampling amnioscope.

28/07/2022

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Rocket Medical® Reproductive Medicine Product Range

Due to on-going raw material supply issues and low sales, we have made the decision to rationalise our Reproductive Medicine Product Range.

01/07/2022

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R53901-L Rocket® Pro-Lux™ Sigmoidoscope - Lubricated

Due to the discontinuation of a key component by our supplier, we are no longer able to manufacture Rocket Medical Pro-Lux™ Sigmoidoscope – Lubricated, product code R53901-L.

01/07/2022

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Discontinuation of Rocket® Needle Guide: Philips Product Code: R57525-00-P2

Following a review of our Reproductive Medicine product range, we have taken the decision to discontinue R57525-00-P2, Rocket Needle Guide: Philips from our Needle Guide portfolio. We sincerely apologise for any inconvenience that this may cause.

01/07/2022

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Discontinuation of Bone Marrowgauge Aspiration Biopsy and Trephine Needles

Following a review of our product lines we have made the decision to discontinue all products from the Bone Marrowgauge Aspiration Biopsy and Trephine Needle Range.

07/04/2022

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Obsolescence of 4 x Diathermy Electrodes

We have taken the decision to discontinue several codes from the Ultra-Fine™ diathermy product range.

06/04/2022

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Discontinuation of R53703, Band-It™ Haemorrhoid Ligator

We have taken the decision to discontinue R53703 Band-It™ Haemorrhoid Ligator from our product portfolio.

06/04/2022

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Temporary Supply Issue for 7FG HSG HyCoSy Catheters

Rocket Medical 7Fg HSG and HyCoSy catheters are currently unavailable due to a supply issue with one of the manufacturing components.

21/03/2022

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ADVICE ONLY

This Customer Information Bulletin is being published to make you aware of a potential issue that has recently been reported to us and to offer clinical advice in the event you experience this issue

21/03/2022

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Changes to R55995-NRFIT Lumbar Puncture Tray

Update to R55995-NRFIT® Lumbar Puncture Tray with NRFit® manometer

02/02/2022

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Rocket Medical Copeland® Fetal Scalp Electrode

Update to Copeland® Fetal Scalp Electrode IFU

04/01/2022

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Rocket Seldinger Chest Drainage Kits

Please be aware that the Instructions for Use (IFU) have been updated to stipulate that the catheter must be sutured into place for R54544-12-PK & R54549-16-PK

10/12/2021

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R53901 Pro-Lux ™ Sigmoidoscope Availability

We regret to inform you that R53901 Pro-Lux™ Sigmoidoscope is currently unavailable due to the discontinuation of a key component by our supplier.

05/11/2021

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Improvements to HSG/HyCoSy Catheters

Addition of Max-Fill label on HSG and HyCoSy Catheters to reduce the risk of balloon rupture.

03/11/2021

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IFU Updates

Please be aware that the Instructions for Use (IFU) have been updated to remove reference to the use of fluoroscopy upon insertion.

01/10/2021

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Discontinuation of R57678 Filter Set for CRAFT™ Suction Pumps

Following a detailed review of our portfolio we have taken the decision to discontinue R57678 Filter Set for CRAFT™ Suction Pumps.

29/09/2021

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Availability of Rocket® Copeland® Fetal Scalp Electrode with Qwik Connector, R57008-00-CN

Rocket Medical is pleased to inform you that the Rocket® Copeland® Fetal Scalp Electrode with Qwik Connector, Product Code R57008-00-CN, is now back in stock.

11/08/2021

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Rocket R54569 PSU Service Procedure Change Request

When the R54569 PSU indicates it requires a service, or the device requires a repair either in or outside of warranty, can this process please be managed through the Medical Physics or EBME department, rather than with your service agent UST directly.

30/07/2021

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Obsolescence of Uriglow Products

Product discontinuation notice for Uriglow™ Transilluminating Ureteric Stent and Uriglow™ Light Coupler.

10/06/2021

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Obsolescence of Welch Allyn Sigmoidoscope Products

Product Discontinuation Notice Obsolescence of Welch Allyn Sigmoidoscopy Products Welch Allyn (Hillrom) are no longer supplying the following sigmoidoscopy products.

12/05/2021

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Droplet Control Shroud for the Single Chest Drain Bottle

The shroud when used in conjunction with the R54571 Filter and R54569 Portable suction unit will allow the PSU to be used on patients with a viral infection such as Covid-19.

08/04/2021

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Discontinuation of Uterine Aspiration Portfolio

Following a review, we have taken the decision to discontinue our Uterine Aspiration product range.

08/04/2021

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Obsolescence of Rocket® FBS Kits Containing Glass Tubes

Following on from our earlier communications on the subject, Rocket Medical confirms that it is no longer manufacturing FBS kits containing glass tubes.

08/04/2021

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Discontinuation of Scissors

Following a review of our Operating Theatre products, we have taken the decision to discontinue all scissors from our product portfolio.

08/04/2021

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Obsolescence of FBS Kits with Standard Blades and Accessories

In the interests of user safety, we will discontinue standard blade kits from 30th June, 2021.

07/04/2021

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Discontinuation of the Rocket® CVS Needle Set

Due to falling demand we have taken the decision to discontinue our Chorionic Villus Sampling needle range.

03/03/2021

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Discontinuation of Rocket® Karman Catheters with Adapter

Following a review of our uterine aspiration portfolio, we have taken the decision to discontinue the Rocket® Karman Catheters with Adapters from this range.

25/02/2021

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Obsolescence of Rocket® FBS Sampling Wand Kit R57021-75-SW

Due to low sales, Rocket® FBS Sampling Wand Kit R57021-75-SW will be discontinued. However, stock remains available for purchase on a first come, first served basis.

25/02/2021

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Discontinuation of R57679 Rocket Filter Set

Following a detailed review of our Oocyte Pump accessories range we have taken the decision to discontinue the R57679 Rocket® Filter Set for Cook Pumps due to low sales

12/02/2021

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DISCONTINUATION OF R57016, R57016-LUME AND R57017 Rocket® FBS Amnioscopes and R57004 Rocket® Amnilume Light Source

Following a detailed review of our FBS accessories range we have taken the decision to discontinue four products due to low sales: R57004, R57016, R57016-LUME and R57017.

26/01/2021

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Changes to Water Trap Sets Supplied with Craft™ Oocyte Pumps Following a review and after customer feedback, we will be making changes to the water trap sets supplied with the Craft™ Suction Pumps.

Discontinuation of Spares for Water Trap Sets Following a review, and due to limited sales, these products will be discontinued with immediate effect. We apologise for any inconvenience caused.

27/11/2020

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Rocket Homecare Portal

Information regarding updated features and funtionality to the Homecare Portal

25/11/2020

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Silicone Thoracic Catheters

With immediate effect we are discontinuing our range of silicon thoracic catheters.

23/11/2020

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DISCONTINUATION OF R57016, R57016-LUME AND R57017

Following a detailed review of our FBS accessories range we have taken the decision to discontinue four products due to low sales: R57004, R57016, R57016-LUME and R57017. We sincerely apologise for any inconvenience that this may cause.

28/10/2020

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Urgent Field Safety Notice Rocket KCH™ Fetal Bladder Drain R57405

Device Destruction

24/09/2020

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Changes to HSG Procedure Packs

Following a review and after customer feedback, we will be making changes to the contents of the HSG Procedure Packs. We will be removing two components: the sanitary towel and the tenaculum. These components are not used in all cases or by all customers. Customers who require these components should put in place plans to source them separately.

16/07/2020

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Discontinuation of Five Oocyte Aspiration Needles

Following a detailed review of our Oocyte Aspiration Needle portfolio we have taken the decision to discontinue five Rocket Medical needle sets. We sincerely apologise for any inconvenience that this may cause.

05/08/2020

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PRODUCT DISCONTINUATION NOTICE: Rocket® EZI Plug Fetal Scalp Electrode Discontinuation

Following a detailed review of our Fetal Scalp Electrode product range, we have taken the decision to discontinue the Rocket® EZI Fetal Scalp Electrode and leg plates.

24/04/2020

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PRODUCT DISCONTINUATION NOTICE: Rocket® Surgi-Hook™: Following a review of our labour ward range, we have taken the decision to discontinue manufacture of the Rocket® Surgi-Hook,™ with immediate effect.

20/04/2020

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PRODUCT DISCONTINUATION NOTICE: Glass Heparinised Tube: Due to falling demand and in line with our previous communication to discontinue glass capillaries by the end of the year (Rocket Medical Customer Information Bulletin, July, 2018), we have now taken the decision to discontinue standalone glass capillaries with immediate effect.

07/04/2020

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Under Water Seal (UWS) chest drains COVID-19: Advice regarding the use of Under Water Seal (UWS) chest drains on COVID-19 patients.

07/04/2020

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Rocket Medical PSU Filter on COVID-19: Advice regarding the use of the Filter material used in the Rocket Medical PSU Filter and the Rocket Medical Pleural Vent on COVID-19 patients.

02/04/2020

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Shortage of Alcohol Swabs for IPC:

UK: Due to Covid-19 there is currently a shortage in the supply of alcohol swabs.

DEU: Aufgrund von Covid-19 besteht derzeit ein Mangel an Alkoholtupfern.

NL: Door Covid-19 is er momenteel een tekort aan alcoholdoekjes.

01/04/2020

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Discontinuation of Needle Guide Packs

Following a review, we have made the decision to discontinue our Needle Guide Packs. We sincerely apologise for any inconvenience that this may cause. The Needle Guides remain available for purchase as standalone products.

24/03/2020

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Discontinuation of Rocket® Embryon™ SOFT™ Embryo Transfer Catheters: Following a detailed review of our Embryo Transfer Catheter portfolio we have taken the decision to discontinue the Rocket® Embryon™ SOFT™ Embryo Transfer (ET) Catheters, product codes R57590 (ET catheter) and R57597 (Trial Transfer Catheter). We sincerely apologise for any inconvenience that this discontinuation may cause.

19/03/2020

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Concerning COVID-19: Rocket Medical really appreciates the importance of our products being available to healthcare providers, especially at this time. This bulletin has been prepared in order to keep our customers updated on our response to the COVID-19 pandemic. This document is an output of our business continuity plan and enables our customers to understand Rocket Medical’s current ability to supply medical devices.

15/03/2020

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Rocket Medical PSU Filter on COVID-19: Advice regarding the use of the Filter material used in the Rocket Medical PSU Filter and the Rocket Medical Pleural Vent on COVID-19 patients.

14/02/2020

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ADVISORY BULLETIN: Rocket® Uripot and Urikone with Wipe We are temporarily unable to supply Uripots or Urikone collection devices with wipes whilst we resolve a manufacturing issue. Equivalent products without wipes are not affected; however, due to an increased level of demand during this period, delays to supply may occur.

14/02/2020

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PRODUCT DISCONTINUATION NOTICE: Rocket® Endometrial and Mucus Sampling Syringes Following a detailed review of our portfolio we have taken the decision to discontinue the Rocket® endometrial and mucus sampling syringes. Due to increasing regulatory costs, it is no longer viable to maintain these products on the market. We sincerely apologise for any inconvenience that this discontinuation may cause.

03/02/2020

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PRODUCT DISCONTINUATION NOTICE: Rocket® Uterine Aspiration Discontinuation Following a detailed review of our surgical product portfolio, we have taken the decision to discontinue several products from our Uterine Aspiration product range.

31/01/2020

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Rocket® Rolonspec Discontinuation

Following a detailed review of our gynaecological instrument product range, we have taken the decision to discontinue the Rocket® Rolonspec vaginal speculum.

31/01/2020

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Rocket® Skin Graft Blade Discontinuation

Following a detailed review of our surgical product range, we have taken the decision to discontinue the Rocket® Skin Graft Blade, Product Code R55170.

31/01/2020

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Discontinuation of Rocket® ESL™ IUI Catheter

Following a detailed review of our IUI portfolio we have taken the decision to discontinue the Rocket® ESL™ IUI Catheter, product code R57621.

19/12//2019

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Approved Service Agent for Rocket® Craft™ and Digital Aspiration Pumps

Rocket Medical plc. are delighted to announce the appointment of IVFSynergy Ltd. as an approved service organisation

10/10/2019

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ADVISORY BULLETIN: Amnioscopios Rocket®: Alternativas al uso de cloroetano.

Se recomienda no utilizar los amnioscopios Rocket® con un aerosol de cloroetano

24/09/2019

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AVIS URGENT DE SÉCURITÉ: Rocket® FBS Amnioscopes de l’utilisation du chlorure d’éthyle sous forme de vaporisation avec les amnioscopes à usage unique Rocket Medical et NuSurgix, fournis séparément, ainsi que dans les kits de prélèvement de sang foetal FBS Rocket® et NuSurgix.

22/08/19

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ADVISORY BULLETIN: Rocket® Amnioscopes: Alternatives to the use of ethyl chloride. We recommend that Rocket® Amnioscopes should not be used with ethyl chloride. Rocket Medical is unable to recommend a specific alternative; however, clinicians may choose to investigate other ways to stimulate hyperaemia:

22/08/19

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PRODUCT DISCONTINUATION NOTICE: Rocket® Cervix Adaptors & Insemination Cups Following a detailed review of the Medical Devices Regulations (EU 2017/745), we have reluctantly concluded the level of regulatory support required cannot be justified in terms of the volume of units sold. Despite their successful use for over 20 years, we must therefore discontinue supply of these products from 1st September 2019 August 2019.

22/08/19

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PRODUCT DISCONTINUATION NOTICE: Rocket® Amniocentesis Needles & Sets Following a detailed review of the Medical Devices Regulations (EU 2017/745), we have reluctantly concluded the level of regulatory support required cannot be justified in terms of the volume of units sold. Despite their successful use for over 20 years, we must therefore discontinue manufacture of these products from 1st September 2019

16/08/19
Revised
18/09/19

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FIELD SAFETY CORRECTIVE ACTION: Rocket® FBS Amnioscopes : issued regarding the use of ethyl chloride spray with Rocket Medical and NuSurgix single use amnioscopes, supplied individually or as part of Rocket® and NuSurgix FBS Kits


10/07/2019

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URGENT FIELD SAFETY NOTICE - We have identified an intermittent issue, which can occur during the manufacture of Rocket® LLETZ Loop Extensions. Affected devices cannot be correctly connected to LLETZ loops.

31/07/18

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PRODUCT DISCONTINUATION NOTICE: As a consequence of multiple factors, Rocket Medical is advising customers of its long term plan to withdraw heparinised long glass tubes from the market by 31st December 2020.

17/11/17
Revised
10/12/2019

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Rocket® Chest Drain Bottles have an antifoaming agent placed into them during the manufacturing process.
This can give the appearance of streaks or smears inside the bottle.

15/08/16
Revised: 17/11/16

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As part of our programme of continuous improvement we are pleased to introduce an update for the R54500 Chest Drainage bottle. There is now an automatic positive pressure relief valve.