FDA Medical Device Recalls (openFDA)
Cook Incorporated: Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
- Recall number
- Z-1840-2022
- Recalling firm
- Cook Incorporated
- Product
- Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
- 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
- 115 US
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Lot, serial or model codes
- RLPC-35-145 G06866 UDI-DI: 00827002068667 Lots/Expiration Date: 14828631 06-07-2025 14828643 06-07-2025 14828644 06-07-2025
- 510(k) numbers
- ["K182985"]
- 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