Recall MonitorHealth Products
A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
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
Recall class: Type II
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.