Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0341-04 · Posted 2004-07-20

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKGZ
Date Initiated2003-12-05
Date Terminated2004-07-30
Product Quantity4,920 units

Reason for Recall

Reports of loosening of the connections and disconnection of the device.

Firm 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.

Root Cause

Other

Distribution Pattern

Canada and the United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031676HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599QBaxter Healthcare Corp · 2003-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑