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
Recall
- Recall Number
- Z-0853-05
- Event Number
- 31275
- Firm
- Baxter Healthcare Corp. Rt.
- FEI Number
- 1416980
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 3, 2005
- Posted
- June 1, 2005
- Terminated
- May 11, 2006
- Address
- 120 & Wilson Rd, Round Lake, IL, 60073
Description
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
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
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.
Nationwide
not known