FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
- Recall number
- Z-2575-2011
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
- Status
- Terminated
- Initiated
- 2011-05-19
- Posted
- 2011-06-22
- Terminated
- 2011-08-01
- Reason
- Kits contain protective wipes that may be contaminated with Bacillus cereus.
- Root cause
- Nonconforming Material/Component
- Action
- Integra LifeSciences consignees were notified by Urgent Medical Device Recall letter on May 20, 2011 and told to quarantine any remaining product and to notify customers to return any remaining product to them. Further information is available at (800) 241-2210.
- Quantity
- 520 kits
- Distribution
- UT
- Lot, serial or model codes
- Lot/Serial Number(s): W1009188, W1009261, W1011070, W1101120, W1102014, W1103011
- 510(k) numbers
- ["K960248"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- 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