FDA Enforcement
Class I
Terminated
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.
Recall: Z-0399-2021
·
Reported November 11, 2020
Enforcement
- Recall Number
- Z-0399-2021
- Event ID
- 86642
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cook Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 11, 2020
- Initiation Date
- October 22, 2020
- Classification Date
- November 3, 2020
- Termination Date
- September 2, 2021
- Address
- 750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States
Description
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.
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 Info
Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931
Distribution
US distribution to AZ, IA, IN, MA, and ND.
Quantity
61 units