FDA Recall Terminated

Baxter Posiflow Access Device for IV Access; product code 2N9050; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the Posiflow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson

Recall: Z-0693-05 · Initiated January 20, 2005

Recall

Recall Number
Z-0693-05
Event Number
31019
Firm
Baxter Healthcare Corp. Rt.
FEI Number
1416980
Product Code
FPA
Status
Terminated
Root Cause
Other
Initiated
January 20, 2005
Posted
April 8, 2005
Terminated
April 14, 2006
Address
120 & Wilson Rd, Round Lake, IL, 60073

Description

Baxter Posiflow Access Device for IV Access; product code 2N9050; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the Posiflow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson

Reason

Product older than three years may not operate as intended.

Action

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.

Distribution

Nationwide, including American Samoa, and internationally to Venezuela.

Quantity

1,585,542 units