Recall Z-1362-2022 ยท DQY Catheter, Percutaneous
Cook Incorporated
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
| Date | May 25, 2022 |
| Status | Completed |
| Reason | The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia. |
| Root cause | Nonconforming Material/Component |
| Action | URGENT: MEDICAL DEVICE RECALL notification letters dated 5/25/22 were sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. Note: Unaffected products that are returned will not be credited. 3. Please c |
| Quantity | 11,451 units |
| Distribution | US Nationwide. Brazil, Canada, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.