—#30707

Product

Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (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 R5C4479Q, lots H03J01492, H03J17027 and H03J24056 and product code N5C4479Q, lots H03I10114, H03I12078, H03J05030 and H03J15088

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 #30707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.