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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Access Marketing Brochures

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  Class 2 Device Recall Bard Access Marketing Brochures see related information
Date Initiated by Firm July 20, 2015
Date Posted September 23, 2015
Recall Status1 Terminated 3 on February 10, 2017
Recall Number Z-2808-2015
Recall Event ID 71757
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
Code Information The brochures were purchased from the vendor on 04/14/2015, Code S120667R0
Recalling Firm/
Manufacturer		 Bard Access Systems
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact Brenda Shelkey
801-522-5974
Manufacturer Reason
for Recall		 Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and PowerPICC¿ SOLO¿ catheters due to incorrect indication for use contained in the brochure.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Customer letter notification with reply form will be sent via Federal Express with delivery confirmation for US consignees on 7/20/15 informing them of the incorrect indication for use contained in the brochure.
Quantity in Commerce 1811
Distribution Distributed to domestic and foreign conference attendees.
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.
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