Z-0341-04

Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French...

Name: Z-0341-04 Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French...
Creator: Baxter Healthcare Corp.
Published: 2003-12-05
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2003-12-05 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL... on 2003-12-05. The reason FDA records is "Reports of loosening of the connections and disconnection of the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0341-04
Status: Terminated
Initiated: 2003-12-05
Posted: 2004-07-20
Terminated: 2004-07-30
Recalling firm: Baxter Healthcare Corporation
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
Product code: KGZ Accessories, Catheter
Reason for recall: Reports of loosening of the connections and disconnection of the device.
FDA 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 in commerce: 4,920 units
Distribution: Canada and the United Kingdom
Product codes and lots: Product code R5C4599Q, lots H03J02029 and H03J27067 and product code N5C4599Q, lots H03I18083, H03I23018 and H03J29022

Product code KGZ

K031676Class IIHomechoice Apd Set with Lineo Connector, Models 5C4469q, 5C4468q, 5C4531q, 5C8302q, 5C4599qBaxter Healthcare Corp / cleared 2003-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)