Drug recall
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424…
FDA recall event 69535 · Class II · Dokitz NovoSci
Key facts
| Event ID | 69535 |
|---|---|
| Recall numbers | Z-0178-2015 |
| Recalling firm | Dokitz NovoSci |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The single leg of the PAY connector has been observed to become detached. |
| Initiation date | Sep 18, 2014 |
| Report date | Nov 12, 2014 |
| Termination date | May 15, 2015 |
| City | Conroe |
| State | TX |
| Country | United States |
| FEI number | 1625519 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: