Cardiopulmonary bypass connector — Class II medical device recall Z-0178-2015
Terminated recall by Dokitz NovoSci, reported 2014-11-12, distributed in IL, MD, MO, PA, TX, UT. The single leg of the PAY connector has been observed to become detached.
| Recall number | Z-0178-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dokitz NovoSci, Conroe, TX, United States |
| Recall initiated | 2014-09-18 |
| Classified | 2014-11-06 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2015-05-15 |
| Distributed | IL, MD, MO, PA, TX, UT |
| Quantity | 240 units |
| Reason classes | device malfunction |
| Lot numbers | 295424 |
| Model numbers | 321334-000 |
| Expiration dates | 2019-05-20 |
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
Reason for recall
The single leg of the PAY connector has been observed to become detached.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0178-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.