Recalls / —
—#37580
Product
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
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K791496, K964918
- Affected lot / code info
- product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; all lots
Why it was recalled
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Baxter Healthcare Corp. Rt.
- Address
- 120 & Wilson Rd, Round Lake, Illinois 60073
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2005-03-03
- Posted by FDA
- 2005-06-01
- Terminated
- 2006-05-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #37580. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.