FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case
- Recall number
- Z-0341-04
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case
- Status
- Terminated
- Initiated
- 2003-12-05
- Posted
- 2004-07-20
- Terminated
- 2004-07-30
- Reason
- Reports of loosening of the connections and disconnection of the device.
- Root cause
- Other
- Action
- Baxter sent recall letters dated 12/5/03 to the accounts in the United Kingdom and recall letters dated 12/8/03 to the accounts in Canada, informing them of the reports of loosening of the connections and disconnection of the device, and requesting that they discontinue use of product codes involved and revert the enrolled patients back to their traditional connection system.
- Quantity
- 4,920 units
- Distribution
- Canada and the United Kingdom
- Lot, serial or model codes
- Product code R5C4599Q, lots H03J02029 and H03J27067 and product code N5C4599Q, lots H03I18083, H03I23018 and H03J29022
- 510(k) numbers
- ["K031676"]
- PMA numbers
- not on file
- Product code
- KGZ
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- 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