Z-0932-05

Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF...

Name: Z-0932-05 Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF...
Creator: Kendall Healthcare Products Co
Published: 2005-04-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-04-27 / Terminated / root cause: packaging

FDA source

Kendall Healthcare Products Co began a recall of Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a... on 2005-04-27. The reason FDA records is "Holes in thermoformed tray compromising the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0932-05
Status: Terminated
Initiated: 2005-04-27
Posted: 2005-06-25
Terminated: 2005-06-27
Recalling firm: Medtronic, Inc.
Product: Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Holes in thermoformed tray compromising the sterility of the product.
Root cause tag: packaging
FDA root cause: Other
Action: Visits by Tyco Sales Reps on 4/27 & 28/2005.
Quantity in commerce: 120 units
Distribution: Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX.
Product codes and lots: 158125 and 158128

Product code LJS

K042461Class IIKendall Argyle 2 Fr Double Lumen Neonatal/pediatric Picc, Model 43304Kendall / cleared 2004-12-10

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)