Recall Z-0851-2019 ยท DYB Introducer, Catheter
Cook Inc.
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
| Date | Dec 21, 2018 |
| Status | Terminated |
| Reason | The products were manufactured with longer than specified sheaths. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall letters dated 12/21/18 were sent to customers. |
| Quantity | 24 |
| Distribution | The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.