Z-1824-2022 Class II Ongoing
FDA device recall Z-1824-2022 was initiated by Cook Incorporated on Aug 16, 2022 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 204 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- Aug 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 204 OUS
Product Description
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 for Recall
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1824-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026