—#30708

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

FDA product code: KGZ — Accessories, Catheter
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K031676
Affected lot / code info: Product code R5C4599Q, lots H03J02029 and H03J27067 and product code N5C4599Q, lots H03I18083, H03I23018 and H03J29022

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Canada and the United Kingdom

Timeline

Recall initiated: 2003-12-05
Posted by FDA: 2004-07-20
Terminated: 2004-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30708. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.