Z-0541-06

Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc

Name: Z-0541-06 Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc
Creator: Bard Access Systems, Inc
Published: 2005-12-20
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2005-12-20 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems, Inc began a recall of Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc on 2005-12-20. The reason FDA records is "Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications...". 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-0541-06
Status: Terminated
Initiated: 2005-12-20
Posted: 2006-03-16
Terminated: 2009-08-11
Recalling firm: Bard Access Systems, Inc.
Product: Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter on 12/20/2005.
Quantity in commerce: 567 units
Distribution: Nationwide, including VA facilities in CA, FL and IL. No foreign or military distribution.
Product codes and lots: Product code 7617405, Lot #REPI0344

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)