Device product
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.
Z-0399-2021
Product summary
- Firm
- Cook Inc.
- Event
- Event 86642
- Status
- Terminated
- Classification
- Class I
- Quantity
- 61 units
- Official record key
device-enforcement:Z-0399-2021
Official wording
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.
Code information: Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931
Distribution pattern: US distribution to AZ, IA, IN, MA, and ND.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter