FDA Medical Device Recalls (openFDA)
Cook Incorporated: Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
- Recall number
- Z-1843-2022
- Recalling firm
- Cook Incorporated
- Product
- Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
- 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
- 149 US
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Lot, serial or model codes
- STF-18-40-AUST G07304 UDI-DI: 00827002073043 Lots/Expiration Date: 14788615 13-06-2027 14816230 28-06-2027 14836977 12-07-2027
- 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