FDA Device recall Z-1829-2022
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire
- 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 (Nitinol), Nitinol Guidewire 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-1829-2022 |
| 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 (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
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-NT-ST G09395 UDI-DI: 00827002093959 Lot/Expiration Date 14809498 23-06-2027 14809499 23-06-2027 148118…PMG-18SP-60-COPE-NT-ST G09395 UDI-DI: 00827002093959 Lot/Expiration Date 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027 PMG-18SP-100-COPE-NT G08687 UDI-DI: 00827002086876 Lot/Expiration Date 14811839 24-06-2027 14839563 13-07-2027 PMG-18SP-60-COPE-NT G08427 UDI-DI: 00827002084278 Lot/Expiration Date 14816750 28-06-2027 14816753 28-06-2027 14816754 28-06-2027 14816755 28-06-2027 14816757 28-06-2027 14821755 30-06-2027 14821756 30-06-2027 14821758 30-06-2027 14831332 07-07-2027 14831333 07-07-2027 14831335 07-07-2027 14831336 07-07-2027 NS14813725 27-06-2027 NS14816751 28-06-2027 NS14821760 30-06-2027 NS14828069 05-07-2027 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027 |
|---|
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-1829-2022%22
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