Device product
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
Z-0178-2015
Product summary
- Firm
- Dokitz NovoSci
- Event
- Event 69535
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 units
- Official record key
device-enforcement:Z-0178-2015
Official wording
Reason: The single leg of the PAY connector has been observed to become detached.
Code information: Model No. 321334-000, lot number 295424
Distribution pattern: MO, TX, PA, IL, MD, UT
Derived failure modes
-
Unknown
The single leg of the PAY connector has been observed to become detached.