Recall Z-0865-2016 ยท DYB Introducer, Catheter
Cook Inc.
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
| Date | Jan 20, 2016 |
| Status | Terminated |
| Reason | Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. |
| Root cause | Under Investigation by firm |
| Action | On 1/20/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235. |
| Quantity | 25 |
| Distribution | Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.