Z-2048-2015Class III

PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The...

Name: Z-2048-2015 PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The...
Creator: Bard Access Systems
Published: 2015-05-27
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2015-05-27 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems began a recall of PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long... on 2015-05-27. FDA classified it as Class III and gives the reason as "Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2048-2015
Classification: Class III
Status: Terminated
Initiated: 2015-05-27
Posted: 2015-07-08
Terminated: 2016-02-10
Recalling firm: Bard Access Systems, Inc.
Product: PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F 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.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Lot No: REYK1762, Item No. 1295108D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2048-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2047-2015	Class III	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08
Z-2048-2015	Class III	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08
Z-2049-2015	Class III	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08
Z-2050-2015	Class III	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08

Product code LJS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)