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U.S. Department of Health and Human Services

Class 2 Device Recall BARD Access Systems

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  Class 2 Device Recall BARD Access Systems see related information
Date Initiated by Firm August 10, 2007
Date Posted September 20, 2007
Recall Status1 Terminated 3 on April 25, 2008
Recall Number Z-1229-2007
Recall Event ID 38621
510(K)Number K844433  
Product Classification Stainless steel guidewire - Product Code MPB
Product Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.
Code Information Product Code 5583705, Lot Numbers: 22FMA202, 22IMO531, 22KMO573, 22DN2914, 22FN5232, 22GN5835, 22GN5878, 22HN6574, 22BO6078, 22BO6163, 22FO6086, 22GO6026, 22HO6101, 22IO6111, 22KO6124, 22CP6268, 22EP6831, REPG0035, REPG0643, REPH0954, REPK0058, REPK0729, REPL0298, REQB0030, REQB0224, REQD0200, REQF0429, REQF0736, REQJ0282, REQK0875, RERC0052, RERD0719. 
Recalling Firm/
Manufacturer		 C.R. Bard Access Systems, Inc
5425 Amelia Earhart Dr
Salt Lake City UT 84116-3713
For Additional Information Contact
801-595-0700
Manufacturer Reason
for Recall		 Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.
Quantity in Commerce 7225 units
Distribution Worldwide, including USA, Canada, Latin America, and Europe (Austria, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, and Sweden).
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 = MPB and Original Applicant = VAS-CATH OF CANADA LTD.
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