Baxter Extension Sets with PosiFlow Access Device for IV… recallZ-0854-05 · Baxter Healthcare Corp. · initiated Mar 3, 2005
Terminated All recalls posted in June 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
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
FDA root cause category: Other
What the company is doing
Urgent Device Correction letters dated 3/3/05 were sent to the direct accounts via first class mail, to the attention of the Director of Nursing. The accounts were informed of the field reports received concerning the PosiFlow Access Device and IV sets containing the PosiFlow device and the changes made to the directions for use and in-service training materials to correct the problems. The accounts were requested to complete and fax back to Baxter at 847-270-5457 the enclosed customer reply form, acknowledging the receipt and dissemination of the information to their staff. Wholesalers were requested to notify their customers. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
Recall details
- Recall number
- Z-0854-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 3, 2005
- Posted by the FDA
- Jun 1, 2005
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- not known
- Product code
- FPA
- FDA submissions
- K791496, K964918
- Distribution
- Nationwide
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
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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