FDA Medical Device Recalls (openFDA)
Cook Incorporated: Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
- Recall number
- Z-1824-2022
- Recalling firm
- Cook Incorporated
- Product
- Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
- 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
- 204 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Lot, serial or model codes
- THSF-35-145-AES-SGH (GPN G06801) - UDI (01)00827002068018(17)270602(10)14767453 - Lot 14767453, Expiration Date 02-06-2027 THSF-38-80-AES-SGH (GPN G06874) - UDI (01)00827002068742(17)270620(10)14802152 - Lot 14802152, Expiration Date 20-06-2027
- 510(k) numbers
- not on file
- 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