Recall Z-0693-05 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
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
| Date | Apr 8, 2005 (initiated Jan 20, 2005) |
| Status | Terminated |
| Reason | Product older than three years may not operate as intended. |
| Root cause | Other |
| 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 lab |
| Quantity | 1,585,542 units |
| Distribution | Nationwide, including American Samoa, and internationally to Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964918 | NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS Critical Device Corp., Apr 14, 1997 |