Date Initiated by Firm | May 27, 2015 |
Date Posted | July 08, 2015 |
Recall Status1 |
Terminated 3 on February 10, 2016 |
Recall Number | Z-2049-2015 |
Recall Event ID |
71420 |
510(K)Number | K072230 K091324 |
Product Classification |
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
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Product | PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain)
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: REYK1764, Item No. 9194108 |
Recalling Firm/ Manufacturer |
Bard Access Systems 605 North 5600 West Salt Lake City UT 84116-3738
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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 |
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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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510(K) Database | 510(K)s with Product Code = LJS
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