A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 79701948 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 80555938 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 79701947 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 80581870 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 80765021 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 79701946 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 80555940 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 80555939 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors | 80581869 | 60-4009-101-00 |
| A.T.S® 4000 TS Tourniquet Systems Dual Hose With CPC Connectors, 20-Pack | More than 10 numbers, contact manufacturer. | 60-1812-101-00 |
Issue
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.
Additional information
Details
Zimmer Surgical, Inc. Also Trading As Relign Corporation
200 W Ohio Avenue, Dover, Ohio, United States, 44622
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