—#38833

Product

Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K002679
Affected lot / code info: product code 560500-250, lots 417521, 418481, 418744

Why it was recalled

The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.

Root cause (FDA determination)

Other

Action the firm took

Baxter sent Urgent Device Correction letters dated 5/4/05 to their customers, to the attention of the Director of Nursing, via first class mail on the same date. The accounts were informed of the one complaint of reverse assembly of the administration set, and were provided with diagrams showing the configuration of a correct assembly and an incorrect assembly of the sets. The accounts were instructed to inspect the sets carefully before use to assure correct assembly. The accounts were requested to destroy any misassembled sets found and complete the certificate of destruction enclosed with the letter, faxing it back to Baxter at 847-270-5457 to receive credit for the destroyed sets.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and internationally to Australia, Belgium, Canada and Japan.

Timeline

Recall initiated: 2005-05-04
Posted by FDA: 2005-08-06
Terminated: 2006-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38833. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.