FDA Device recall Z-0399-2021
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517
- FDA Device
- Class I
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class I recall of Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517 by Cook, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0399-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-10-22 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | AZ, IA, IN, MA, ND |
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.
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.
Identifiers
| code_info | Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0399-2021%22
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