Recalls / —
—#37007
Product
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
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K964918
- Affected lot / code info
- product code 2N9050; 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 #37007. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.