FDA Device recall Z-1830-2022
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G0…
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G0… 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-1830-2022 |
| 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
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
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 | PMG-18SP-60-COPE G05183 UDI-DI: 00827002051836 Lot/Expiration Date 14795012 15-06-2027 14801636 20-06-2027 14804264 21-…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 |
|---|
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-1830-2022%22
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