Ethicon, Inc.: Surgical Sutures Recalled for Compromised Sterility and Infection Risk

What You Should Do

1. Identify if you have the affected sutures by checking the Product Code and Lot Number on the individual sterile pouch or the box label. Affected brands include VICRYL, VICRYL Plus, PDS II, PDS Plus, MONOCRYL, and MONOCRYL Plus.
2. For VICRYL (polyglactin 910) sutures, look for product codes J214H, J218H, J258H, J268H, J269H, J327H, J344H, J345H, J370H, J416H, J417H, J426H, J427H, J458H, J493H, J603H, J699H, J936H, or J978H with lot numbers such as UAMPJQ, UBMJSK, or UBMHSJ.
3. For MONOCRYL sutures, check for product codes such as Y315H, Y345H, Y359H, Y398H, Y416H, Y417H, Y426H, Y427H, Y935H, Y936H, or Y945H with corresponding lot codes like UAMQCX or UBMCAJ.
4. Immediately stop using any sutures from the affected lots and quarantine them to prevent accidental use in surgical procedures.
5. Contact Ethicon, Inc. or your healthcare facility's supply chain department to arrange for the return of the affected products and to receive replacements.
6. Healthcare providers should monitor any patients who may have had these sutures used in recent procedures for signs of infection.
7. For further questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products