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Customer Information Bulletins - US

Customer Information Bulletins - US

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

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.

27/01/2021

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Temporary Colour Change for Marker Beads on Embryon Genesis™ and EchoCath™ Embryo Transfer and Trial Transfer Catheters

Due to a supplier issue, we will temporarily change the colour of the marker bead, on the Embryon Genesis™ and EchoCath™ Embryo Transfer and Trial Transfer Catheters from green to blue.

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.

17/03/16
1st pub: 29/01/14

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Use of Rocket® KCH™ Catheters with MRI - ADVISORY BULLETIN