A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors

Product A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors Issue Medical devices - Sterility What to do Contact the manufacturer if you require additional information. Audience Healthcare

Zimmer Biomet is conducting a medical device recall for A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors. One (1) complaint was received with no clinical impact reporting that wrinkles were identified in the sealing area of the sterile pouch. Subsequent seal integrity testing conducted internally showed potential sterility breach in 0.92% of inspected units that had visual seal nonconformities. The devices are distributed in cases (CS) of 20 units. Inside each case are two boxes (BX) of 10 units each.

RA-82244