Ethicon, Inc. US PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

Recommended Action

Per FDA guidance

Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative. 5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.

Distribution

As reported by FDA

PR