Recall Z-1713-2022 ยท DQX Wire, Guide, Catheter
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
| Date | Jul 19, 2022 |
| Status | Open, Classified |
| Reason | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. |
| Root cause | Under Investigation by firm |
| Action | Cook notified consignees by Urgent Medical Device Recall Letter on July 19, 2022. Letter states reason for recall, health risk and action to take: Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 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. 3. Please complete the Acknowledgement a |
| Quantity | 5400 units |
| Distribution | Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110009 | ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE Cook, Inc., Feb 2, 2011 |