FDA Medical Device Recalls (openFDA)
Cook Incorporated: 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
- Recall number
- Z-1830-2022
- Recalling firm
- Cook Incorporated
- 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
- Status
- Open, Classified
- Initiated
- 2022-08-16
- Posted
- 2022-09-28
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
- Quantity
- 2,748 US; 302 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K171997
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28