Baxter Extension Sets with Posiflow Access Device for IV… recallZ-0694-05 · Baxter Healthcare Corp. · initiated Jan 20, 2005
Terminated All recalls posted in April 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product older than three years may not operate as intended.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0694-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 20, 2005
- Posted by the FDA
- Apr 8, 2005
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 1,585,542 units
- Product code
- FPA
- FDA submissions
- K791496, K964918
- Distribution
- Nationwide, including American Samoa, and internationally to Venezuela.
Product description
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
Code information (models, lots, serial numbers)
product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; all lots without expiration dating
Other devices under the same FDA submission
1 device cleared under K791496, K964918 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 2C1145Baxter International Inc. · Set, administration, intravascular2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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