Product Recall Rocket Medical Safety Needle Drain 8fg x 16cm Paracentesis Catheter with Blunt Obturator Needle (ICN 2682)

MHRA TBC

NHSSC Ref: 48

Alert:

• Rocket Medical has issued a Field Safety Notice withdrawing a single Lot number of their 8fg Safety Needle having identified that during production the adhesive/glue used to secure the drainage line to the stitch plate was not correctly applied.
• As a result, the drainage line may separate from the tap.
• Please note users should not attempt to secure the tap with tape, this is not an acceptable fix.

Products Affected:

•  The product affected is available from NHS Supply Chain:

• Please note only the Lot number quoted in the Field Safety Notice is affected.
• Rocket Medical advise this withdrawal should have no impact on future availability.
• NHS Supply Chain has checked current stock, and all future issues will be of different, unaffected, Lot numbers.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine the affected Lot number.
• Maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the recall notice.
• Contact your local NHS supply Chain Customer Service Advisor with full details of affected products including if the quantity is in the unit of issue, box 5, or eaches. Your Customer Service advisor will confirm details and provide you with a unique CMS reference.
• Dispose of the affected products in accordance with your local regulations.
• On receipt of written confirmation, quoting your unique reference number, credit for the full value of the product destroyed will be raised.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.