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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter PosiFlow Access Device for IV Access

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  Class 2 Device Recall Baxter PosiFlow Access Device for IV Access see related information
Date Initiated by Firm March 03, 2005
Date Posted June 01, 2005
Recall Status1 Terminated 3 on May 11, 2006
Recall Number Z-0853-05
Recall Event ID 31275
510(K)Number K964918  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product 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
Code Information product code 2N9050, all lots
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce not known
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = CRITICAL DEVICE CORP.
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