FDA Device recall Z-1824-2022
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY)
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY) by Cook, citing cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1824-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-16 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook |
| Distribution | US |
Product
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
Reason
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Identifiers
| code_info | THSF-35-145-AES-SGH (GPN G06801) - UDI (01)00827002068018(17)270602(10)14767453 - Lot 14767453, Expiration Date 02-06-2…THSF-35-145-AES-SGH (GPN G06801) - UDI (01)00827002068018(17)270602(10)14767453 - Lot 14767453, Expiration Date 02-06-2027 THSF-38-80-AES-SGH (GPN G06874) - UDI (01)00827002068742(17)270620(10)14802152 - Lot 14802152, Expiration Date 20-06-2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1824-2022%22
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