—#37327

Product

Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with Posiflow Positive Displacement Feature; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the Posiflow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K791496, K964918
Affected lot / code info: product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; all lots without expiration dating

Why it was recalled

Product older than three years may not operate as intended.

Root cause (FDA determination)

Other

Action the firm took

Urgent Product Recall letters dated 1/20/05 were sent to the direct accounts via first class mail, to the attention of the Director of Purchasing. The accounts were informed that the Posiflow Luer Activated valves may not operate as intended if the product is older than three years. The accounts were instructed to examine their inventories of the affected product codes listed to determine if they have any product on hand without expiration dating, and remove any found from inventory. The expiration date, if present, may be found on both the individual product package and on the end panel label of the product shipping carton. The accounts were instructed to call Baxter at 1-888-229-0001 to arrange for the return of any product found without an expiration date. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, including American Samoa, and internationally to Venezuela.

Timeline

Recall initiated: 2005-01-20
Posted by FDA: 2005-04-08
Terminated: 2006-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37327. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.