Z-0587-04

BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile

Name: Z-0587-04 BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile
Creator: Becton Dickinson Infusion Therapy
Published: 2004-02-03
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2004-02-03 / Terminated

FDA source

Becton Dickinson Infusion Therapy began a recall of BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile on 2004-02-03. The reason FDA records is "Splittable catheter introducer may not fully split or may separate non-uniformly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0587-04
Status: Terminated
Initiated: 2004-02-03
Posted: 2004-07-20
Terminated: 2004-06-10
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Splittable catheter introducer may not fully split or may separate non-uniformly.
FDA root cause: Other
Action: On 02/03/2004, all consignees were notified by telephone and letter.
Quantity in commerce: 12000 units
Distribution: Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
Product codes and lots: Catalog Number 380402, Lot Numbers 3356877, 3356485, 3352218.

Product code FOZ

K974764Class IIIntrosyte CatheterBecton Dickinson Infusion Therapy Systems, Inc. / cleared 1998-02-26

MDM coverage of this record lists here, newest first.

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)