Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2
FDA device recall Z-0694-05 · posted 2005-04-08 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Product older than three years may not operate as intended.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 1,585,542 units
- Distribution
- Nationwide, including American Samoa, and internationally to Venezuela.
- Date initiated
- 2005-01-20
- Date posted
- 2005-04-08
- Date terminated
- 2006-04-14
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS (K964918) | Critical Device Corp. | 1997-04-14 |
| LOW PLASTICIZER ADMINISTRATION SETS (K791496) | Travenol Laboratories, S.A. | 1980-04-08 |