Device product
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Z-1959-2014
Product summary
- Event
- Event 68398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 195 Cases; Total 1170 units
- Official record key
device-enforcement:Z-1959-2014
Official wording
Reason: Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.
Code information: Lot Number: 10906458
Distribution pattern: Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
Derived failure modes
-
Unknown
Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.