Field Safety Notice Sterile Barrier Breach of Breather Pouch in Non-Absorbable Sutures (ICN 1922)

MHRA TBC

Recall Ref: 71

Alert:

• The Supplier Medtronic has initiated a precautionary recall for specific Lots of Non-Absorbable Sutures following discovery of manufacturing errors in the packaging which may cause a gap or wrinkle in the breather pouch resulting in a sterile barrier breach.
• The potential harm(s) of a sterile barrier breach include infection or vision loss for ophthalmic procedures in cases where there is direct patient contact.
• Medtronic advise as of 1 November 2022 they have received no complaints of packaging integrity defects or reports of serious patient injury related to this issue.

Products Affected:

• See our Downloads ▼ section to refer to the product listing for further information on the affected product codes and the potential indirect alternatives.
• Please note, only the product codes and Lot numbers list on attachment A (page 4) of the Field Safety Notice are affected.

 Next Steps:

• Please read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Share this notice with all who need to be aware within your organisation or to any organisation where the potentially affected products has been transferred or distributed.
• Where affected product/ Lot numbers are identified, please contact your NHS Supply Chain Customer Service Advisor with full details of all products, including Lot numbers and whether quantities are in eaches or pack of unit of issue.
• Medtronic will arrange to collect affected eDirect products in your possession on receipt of a completed Customer Verification Form emailed to regulatoryuk-ire@medtronic.com
• NHS Supply Chain will raise credit for products collected by Medtronic.
• Products supplied via NHS Supply Chain warehouses (stock) will be collected by NHS Supply Chain for full credit (reason code 7 Supplier Recall).
• All goods to be collected no later than Friday 20 January 2023.

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