ETHICON, LLC: PDS II and PDS Plus Sutures Recalled for Low Tensile Strength

What You Should Do

1. Identify if you have the affected PDS Plus Antibacterial sutures by checking for Product Numbers such as PDP072H40, PDP259H50, PDP416H50, PDP441H50, and others, or PDS II sutures with numbers like Z844G-50, D10065-05, and Z259H-50.
2. Check the packaging for the following lot numbers: RLMCKU, RLMEAL, RLMDST, RMMHLT, RJMMAC, SCMASA, RKMQDX, RKMBEB, SAMERU (for PDS Plus) or RGMBEK, QMMCKS, QLMKHK, REMMRB, RKMASZ, PBM649, and others listed in the product data (for PDS II).
3. Verify the Unique Device Identifier (UDI-DI) on the label, which includes codes like 10705031122574, 10705031047952, or 10705031026742.
4. If you are a healthcare provider, immediately stop using the affected lots and quarantine any remaining stock.
5. If you are a patient who has recently undergone surgery involving these sutures, contact your healthcare provider or surgeon if you have concerns about your incision site or healing process.
6. Contact Ethicon at their Guaynabo office or through your local representative for instructions on returning the product and receiving a potential refund or replacement.
7. For additional questions, 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