Z-1830-2022 Class II Ongoing
FDA device recall Z-1830-2022 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: 2,748 US; 302 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- Aug 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,748 US; 302 OUS
Product Description
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
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
PMG-18SP-60-COPE G05183 UDI-DI: 00827002051836 Lot/Expiration Date 14795012 15-06-2027 14801636 20-06-2027 14804264 21-06-2027 14804265 21-06-2027 14806984 22-06-2027 14806985 22-06-2027 14815841 27-06-2027 14815842 27-06-2027 14815852 27-06-2027 14815853 27-06-2027 14815854 27-06-2027 14819080 29-06-2027 14819081 29-06-2027 14831205 07-07-2027 14831206 07-07-2027 14841236 14-07-2027 PMG-18SP-100-COPE G05822 UDI-DI: 00827002058224 Lots/Expiration Dates 14797819 16-06-2027 PMG-18SP-125-COPE G10077 UDI-DI: 00827002100770 Lots/Expiration Dates 14809295 23-06-2027 14809296 23-06-2027
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1830-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026