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Customer Information Bulletins - US

Customer Information Bulletins - US


Customer Information Bulletins are an important source of key 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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document

Bulletin details

03/05/17

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FIELD SAFETY NOTICE: We have been made aware that a number of Rocket® Yankaeur Suction tubes may contain a powder-like substance within the pack and or tube. We therefore have decided, as a precautionary measure, to recall R22610-S LOT: 471722

03/05/17

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PRODUCT DISCONTINUATION NOTICE: Following a commercial and quality review of our sterile and non-sterile instrument ranges, we have reluctantly decided to discontinue supply of our sterile and non-sterile Rocket® Tonsillectomy Range with effect from 1st May 2017.

10/03/17

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Rocket Medical do not supply capillary sample tube ‘mixing wires’ in Rocket® FBS Kits and we do NOT recommend their use.

09/03/17

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As part of our programme of continuous improvement, we are pleased to introduce a packaging upgrade for the
Rocket Medical R51551 Thoracentesis Kits.

21/02/17

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We are making a minor change to the gauze swabs supplied in our Rocket® Fetal Blood Sampling, IPC™ Indwelling Pleural Catheter Insertion sets and HSG Packs.

20/02/17

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Rocket® Seldinger Chest Drain and IPC™ insertion kits are now supplied a smaller tray to reduce the amount of packaging materials and storage requirements in line with our environmental policy.

23/11/16

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Rocket® Portable Suction Unit (PSU) Product Evaluation - Important User Information. The supply of Rocket Medical equipment for evaluation is done so exclusively under the terms and conditions of the NHS Master Indemnity Agreement (MIA).

23/11/16

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PRODUCT DISCONTINUATION: Following a detailed review of the manufacturing process for R57683 & R57684 Rocket® Sialography Catheters we have reluctantly decided to discontinue these codes.

26/09/16

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We have identified a potential problem with a small proportion of R57003-EZI Rocket® EZI Plug Fetal Scalp Electrodes where the two halves of the finger grip have separated and in isolated cases become detached

15/08/16

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As part of our programme of continuous improvement, we are pleased to introduce changes to the
R54543 Triple Chamber Chest Drain.

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.

27/07/16

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PRODUCT RECALL: Rocket Medical would like to inform you that an issue has been highlighted during the sterilization process of R51551 Thoracentesis Catheter, LOT 468113.

27/07/16

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Rocket Medical would like to inform you that due to a manufacturing irregularity, one of the accessory components supplied with the Rocket® R54565 Pleural Vent does not perform as required.

18/04/16

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Rocket Medical is to discontinue supply of reusable stainless steel instruments with effect from: 5th April 2016. There are some exceptions where instruments support other products. Details are included in this bulletin

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

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

22/01/16

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Rocket® FBS Kits: As part of our continuous improvement programme, we are upgrading our Rocket® FBS Kits by introducing a new longer, ‘double ended’ capillary tube holder. .

07/12/15

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Rocket ProLux™Sigmoidoscope and Proctoscope battery storage. As an environmentally responsible company, Rocket Medical plc. provides its customers with the choice to remove the battery cells from our Pro-Lux™ range of self-illuminating endoscopes prior to disposal, should they wish to do so. To avoid the risk of multiple cells coming into contact with each other and causing a short-circuit, place the lid onto the tray when filled and tape securely into position at the mid point of each side.

23/11/15

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Unfortunately do to a supply issue, for the short term, we are unable to supply the usual guide wire in the following
Rocket Medical Seldinger Kits.
R54544-12-SG, R54544-12-PK, R54549-16-PK, R54544-18-SG, R54544-18-PK, R54549-20-PK

14/10/15

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We are upgrading all of our Rocket® and NuSurgix® FBS Sampling Wands by introducing a new blade and blade mounting. As part of our continuous improvement programme, we have modified the blade width and added a dual bevel to increase sharpness and improve penetration of the fetal scalp.

28/08/15

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DISCONTINUATION: R57440 Rocket Perfguard™ Disposable Uterine Manipulator. Following a detailed production and design review of the manufacturing tools, we have concluded that they are now beyond economic repair and restoration. As a result we are reluctantly compelled to discontinue supply of the product.

28/08/15

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R57065 Rocket Amniotomy Hook. We are making improvements to our by introducing an entirely new moulding. The existing manufacturing tools have reached the end of their service life and are being replaced. As part of our continuous improvement programme, we have taken the opportunity to re-design the overall handle shape and the increase the rigidity of the hook profile.

29/07/15

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We are making improvements to our Rocket FBS Amnioscope and Amnilume range by introducing a new design. The changes, which affect both amnioscope and light source modules, are being introduced from July 2015 onwards and will affect all Rocket FBS Kit and amnioscope accessories. As the components of the original and new styles are not interchangeable, there is the possibility of confusion between different product versions bearing the same product code. After a review, it has been decided that the new versions will have new product codes to aid easier identification in distributor and end-user stock rooms.

24/07/15

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Rocket Medical plc. are delighted to announce the appointment of Hunter Scientific Ltd. as the approved service organisation for all versions of Rocket Craft and Digital Suction Pumps in the UK. From August 1st, 2015 UK customers requiring routine annual servicing or repairs for their Rocket oocyte aspiration pumps should contact Hunter Scientific. Contact details are in the attached bulletin.

02/06/15

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We are making improvements to the Rocket Amnioscope and Amnilume™ contained in our Rocket FBS Kit and are introducing a new design with additional benefits. These are being introduced from June 8th 2015 onwards and will affect all Rocket standard and sampling wand FBS Kits.

20/05/15

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We are making design changes, which affect the Rocket amnioscope and Rocket Amnilume light source modules. These are being introduced from June 2015 onwards and will initially affect the R57016-LUME and the R57016-PLUS amnioscope sets.

24/02/15

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We have been notified by Cryo Bio Systems that they will no longer supply their Embryo Crystal Straws to Rocket Medical plc. We have distributed the CBS Embryo Crystal Straw for many years and will continue to supply our loyal customers whilst our few remaining stocks last.

28/11/14

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Rocket Craft™ DUO-VAC and Craft™ Suction Pumps – gauge upgrade In-line with our policy of continuous improvement, we have upgraded the vacuum gauge on all Rocket Craft™ DUO-VAC and Craft™ Suction Pumps with effect from 1st January 2015. The changes include a larger and more accurate gauge to improve the quality of vacuum control and the ease of visibility.

10/11/14 Updated 19/11/14

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Supply of MityVac range of obstetric vacuum cups: We have been notified by Cooper Surgical Inc. that they will no longer supply the Mityvac range to Rocket Medical with effect from December 1st 2014. We will continue to supply our loyal customers whilst our existing stocks last.

28/10/14

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Rocket Bandit™ Haemorrhoid Ligators - Handle colour change: Following the acquisition of NuSurgix Ltd in January of 2014, Rocket Medical plc have merged their colorectal products into the Rocket portfolio under the Rocket brand name. We also supply the Bandit™ haemorrhoid ligator under an own label manufacturing agreement to Pennine. To avoid confusion between the two products in market, we have divided the two distribution routes by colour.

16/09/14

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FIELD SAFETY NOTICE: A manufacturing irregularity has occurred during the production of the R54400, R54400-00-PP, R54410, R51400, R51400-00-PP IPC drainage bottles. A small number of drainage bottles have appeared to malfunction as the blue connector tube has not opened once the white clip has been moved.

29/08/14

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Delivery Charges from 1st September 2014: With effect from 1st September 2014 our standard delivery charge for orders over £50.00 will increase to £10.95 per delivery. This is in response to significant increases in carriage and transport costs across the industry and is in line with our normal terms and conditions of sale.

10/06/14

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With effect from 1st March 2014 Rocket Medical are the appointed distributor for the Welch Allyn range of disposable and reusable Sigmoidoscopes, proctoscopes, light handles and accessories. Orders should be placed either with NHS Supply Chain or with Rocket Medical Customer Service team on Tel: 019 419 6988 Email: customer services@rocketmedical.com

05/06/14

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Rocket Medical plc. provides customers with the choice to remove the battery cells from our Pro-Lux range of self-illuminating endoscopes prior to disposal, should they wish. We provide Instructions for Use with the product to enable our customers to complete this procedure should they need to comply with local hospital or NHS Trust policies which specifically require the removal of battery cells prior to disposal.

16/04/14

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Supply of Rocket HSG, HyCoSy & Sonohystogram Catheters in Australia. With immediate effect, all Rocket HSG Catheters are fully available directly from our preferred logistics partner CH2. These product were formally distributed by Gytech Pty.

12/02/14

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Order point changes following the acquisition of NuSurgix Ltd. Following the acquisition of NuSurgix Ltd by Rocket Medical plc on 21st Jan 2014, the Customer Services and Quality Assurance functions will be transferred to Rocket on 1st March 2014. As a result, all future orders for the NuSurgix products listed should now be made via Rocket Medical Customer Services.

30/01/14, Revised 10/02/14

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Rocket Medical announce the acquisition of NuSurgix Ltd. Rocket Medical plc are delighted to announce that with effect from Tuesday 21st January 2014 the company has acquired NuSurgix Limited, Consett, County Durham. UK. Customer Service and manufacturing functions will be transferred to Rocket Medcial plc on 1st March 2014

13/01/14

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Rocket Uterine Sound - DESIGN CHANGE. The mould tooling for this product has come to the end of its service life and has now been replaced. As part of our programme of continuous improvement we have taken the opportunity to improve the design of the sound which will be introduced from Jan 2014.