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
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Bulletin details
23/12/2022
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 possible23/12/2022
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 possible23/12/2022
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 possible28/09/2022
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
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
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
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
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
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
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
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
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
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
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
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 issue21/03/2022
Changes to R55995-NRFIT Lumbar Puncture Tray
Update to R55995-NRFIT® Lumbar Puncture Tray with NRFit® manometer02/02/2022
Rocket Medical Copeland® Fetal Scalp Electrode
Update to Copeland® Fetal Scalp Electrode IFU
04/01/2022
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-PK10/12/2021
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
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
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
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
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
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
Obsolescence of Uriglow Products
Product discontinuation notice for Uriglow™ Transilluminating Ureteric Stent and Uriglow™ Light Coupler.10/06/2021
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
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
Discontinuation of Uterine Aspiration Portfolio
Following a review, we have taken the decision to discontinue our Uterine Aspiration product range.08/04/2021
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
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
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
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
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
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
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 sales12/02/2021
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
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
Rocket Homecare Portal
Information regarding updated features and funtionality to the Homecare Portal25/11/2020
Silicone Thoracic Catheters
With immediate effect we are discontinuing our range of silicon thoracic catheters.23/11/2020
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
Urgent Field Safety Notice Rocket KCH™ Fetal Bladder Drain R57405
Device Destruction24/09/2020
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 organisation10/10/2019
ADVISORY BULLETIN: Amnioscopios Rocket®: Alternativas al uso de cloroetano.
Se recomienda no utilizar los amnioscopios Rocket® con un aerosol de cloroetano24/09/2019
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
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
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
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
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
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
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
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
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.
