Z-0285-06

16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte

Name: Z-0285-06 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
Creator: Becton Dickinson Medical Systems
Published: 2005-03-25
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2005-03-25 / Terminated

FDA source

Becton Dickinson Medical Systems began a recall of 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte on 2005-03-25. The reason FDA records is "Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0285-06
Status: Terminated
Initiated: 2005-03-25
Posted: 2005-12-15
Terminated: 2011-08-08
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
FDA root cause: Other
Action: Consignees were notified via telephone and fax letter, beginning 04/25/2005.
Quantity in commerce: 5740 units
Distribution: AL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan.
Product codes and lots: REF 384426

Product code LJS

K920755Class IIL-Cath Peel Away System CatheterLuther Medical Products, Inc. / cleared 1993-06-07

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)