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U.S. Department of Health and Human Services

Class 3 Device Recall PowerPICC SOLO Catheter

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  Class 3 Device Recall PowerPICC SOLO Catheter see related information
Date Initiated by Firm May 27, 2015
Date Posted July 08, 2015
Recall Status1 Terminated 3 on February 10, 2016
Recall Number Z-2047-2015
Recall Event ID 71420
510(K)Number K091324  K072230  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer
The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Code Information Lot No: REYK1763, Item No. 1194108D
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact Brenda Shelkey
801-522-5974
Manufacturer Reason
for Recall		 Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
FDA Determined
Cause 2		 Labeling Change Control
Action BARD sent an Urgent Notification letter dated May 27, 2015, to all affected consignees via FedEx. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that they may choose to return the affected product to Bard Access Systems or use with the understanding that the correct expiration date is November 2015 (2015-11). Customers with questions were instructed to call 1-800-290-1689. For questions regarding this recall call 801-522-5974.
Distribution Nationwide Distribution
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 = LJS and Original Applicant = C.R. BARD, INC.
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