FDA Medical Device Recalls (openFDA)
Integra Pain Management: Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791
- Recall number
- Z-1635-2008
- Recalling firm
- Integra Pain Management
- Product
- Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791
- Status
- Terminated
- Initiated
- 2008-03-18
- Posted
- 2008-08-14
- Terminated
- 2008-11-05
- Reason
- Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.
- Root cause
- Nonconforming Material/Component
- Action
- Integra notified the consignee by letter on 03/18/2008. Instructions were to cease distribution/use of the affected kits and arrange for return to Integra. Also, consignee was instructed to notify all customers who received the kits to cease use and return any affected product for further disposition.
- Quantity
- 500 kits
- Distribution
- CO
- Lot, serial or model codes
- Lot Numbers: W0801021, W801104, W0711154.
- 510(k) numbers
- ["K960248"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1000138491
- Firm city
- Salt Lake City
- Firm state
- UT
- 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