Recall Z-0953-2018 ยท DQX Wire, Guide, Catheter
Cook Inc.
Bentson Wire Guide
| Date | Oct 13, 2017 |
| Status | Terminated |
| Reason | Label does not state that the product is heparin-coated. |
| Root cause | Labeling Change Control |
| Action | On October 31, 2017 an URGENT MEDICAL DEVICE CORRECTION was issued to customers requesting the following, including a corrective action: Step 1: Determine if your product is included in the affected lot ranges by comparing your lot number to the listing provided. " If your product is not affected, complete the Acknowledgement and Receipt Form. " If your product is affected, proceed to Step 2. Step 2: Remove a Heparin Coated label from the label sheet provided and apply to the top right corner of your affected unit. o If you need additional labels, please contact Stericycle at 855.215.4967. If |
| Quantity | 439,797 |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.