Field Safety Notice 3M Healthcare Steri Drape Surgical Drapes (ICN 1846)

MHRA TBA
Recall Reference: 55

Alert:

• 3M Healthcare (3M) has issued a Field Safety Notice affecting its range of Steri Drape surgical drapes following a recent investigation confirming that the liner on the adhesive component of the drape is difficult to remove without damaging the product and may render the product unusable.
• Additionally, 3M has observed an increase in reported adhesive related skin injuries for the affected Lots.
• Although the performance acceptance criteria for the device was met upon product release, the adhesive component may not meet 3M’s performance criteria throughout the product shelf life.

Products Affected:

• Eight of the affected product codes are available from NHS Supply Chain, three stocked and five via the Blue Diamond route. Please see our Downloads section to refer to the attachment for full details on the product codes and affected lot numbers.
• Please note these products will be suspended and unavailable to order as 3M advise they do not anticipate supplies to resume until 2023.
• Customers will need to choose alternative drapes.
• Potential alternatives are listed in the attachment.
• Customers are advised to consult their own clinical experts to ensure suitability for their organisation’s use of these products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Where affected product/batch numbers are identified, cease use and contact your NHS Supply Chain Customer Service Advisor as soon as possible with full details. Please confirm if the quantities in your possession are singles or pack of our unit of issue.
• Your Customer Service Advisor will give you a unique reference number and request you dispose of all affected batch numbers in accordance with your local regulations.
• On email confirmation of disposal, quoting your unique reference number (URN), you will receive credit for the full value of the goods.

If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Service Advisor.