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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 Cathetersee related information
Date Initiated by FirmMay 27, 2015
Date PostedJuly 08, 2015
Recall Status1 Terminated 3 on February 10, 2016
Recall NumberZ-2047-2015
Recall Event ID 71420
510(K)NumberK072230 K091324 
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
ProductPowerPICC 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 ContactBrenda 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
ActionBARD 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.
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LJS
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