Recall Z-0399-2021 ยท DQX Wire, Guide, Catheter
Cook Inc.
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
| Date | Nov 3, 2020 (initiated Oct 22, 2020) |
| Status | Terminated |
| Reason | Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide. |
| Root cause | Process control |
| Action | On October 22, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to take the following actions: 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. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you |
| Quantity | 61 units |
| Distribution | US distribution to AZ, IA, IN, MA, and ND. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.