Recall Z-1780-2019 ยท KGZ Accessories, Catheter
Cook Inc.
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
| Date | May 2, 2019 |
| Status | Terminated |
| Reason | The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 5/2/19 were sent to customers. |
| Quantity | 97 |
| Distribution | No distribution in the US. Products were distributed to the following foreign countries: China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.