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.
This recall has been terminated (originally issued July 8, 2015).
- Company
- Bard Access Systems
- Recall Initiated
- May 27, 2015
- Posted
- July 8, 2015
- Terminated
- February 10, 2016
- Recall Number
- Z-2049-2015
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
Distribution
Nationwide Distribution
Lot / Code Info
Lot No: REYK1764, Item No. 9194108
Root Cause
Labeling Change Control
Action Taken
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.