—#28405

Product

Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111'', Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.22 Micron Extended Life Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8857; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K003225, K981792
Affected lot / code info: catalog 2C8857, lot numbers UR134353 through UR157545. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.

Why it was recalled

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Root cause (FDA determination)

Other

Action the firm took

Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan

Timeline

Recall initiated: 2003-07-16
Posted by FDA: 2003-08-21
Terminated: 2004-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28405. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.