Z-0399-2021 Class I Terminated
FDA device recall Z-0399-2021 was initiated by Cook Inc. on October 22, 2020 and is designated Class I. Reason for recall: 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. The recall status is terminated (terminated September 2, 2021). Affected quantity: 61 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- October 22, 2020
- Termination Date
- September 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Product 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 for Recall
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.
Distribution Pattern
US distribution to AZ, IA, IN, MA, and ND.
Code Information
Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931