Important Safety Alerts

Medical device manufacturer, Medtronic, has issued a medical safety alert concerning its Polysorb braided and Biosyn monofilament absorbable sutures. The affected products are identified as follows:-

• Item Code: CL461, CL537, CL811, CL815, CL885, CL892, CL 911, CL914, CL915, CL923, CL925, CL953, GL123, GL124, GL228, GL323, GLS322, L1742K, L2752K, SL1625G, SL5679, SL5690, SL654, UL203, UL877, UL878, UM201
• Lot Number: D7H0876X, A9J0018Y, A9J0075Y, A9H1170Y, A9H1065Y, A9J0006Y, D7H1048Y, A9H1186Y, A9J0015Y, A9H0927Y, A9H1187Y, A9J0383Y, A9J0428Y, A9H1189Y, A9J0345Y, A9J0014Y, A9J0193Y, A9K0004Y, A9J0421Y, A9J0053Y, D7H0794X, A9J0384Y, D7G0387X, D7H1126X, D7H1092X, D7H1214X, A9H0847FY, D7G2298X, D7H0091X, D7H0946X, D7G2301X, D7H0092X, D7H0796X, D7H0866X, D7H0404X
• These devices expire between July 2022 and September 2024.

According to the manufacturer, the voluntary recall is being conducted due to the potential for packaging integrity issues impacting the humidity or sterility barrier of the affected products. These conditions may result in premature degradation of the suture material or compromise the product's sterile condition.

The use of products with an incomplete seal of the humidity barrier may increase the potential for the suture to break. The use of products with a compromised sterile barrier may result in a potentially increased risk for infection.

There have been no reports of patient injury associated with these issues.

Affected users are required to take the following actions:

• Immediately quarantine and discontinue use of the affected item codes and lots
• All unused products from the affected item codes and lots must be returned

Product recall is on-going.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 19 December 2019