Z-0084-04

Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm

Name: Z-0084-04 Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm
Creator: Arrow International Inc
Published: 2003-09-16
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2003-09-16 / Terminated

FDA source

Arrow International Inc began a recall of Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm on 2003-09-16. The reason FDA records is "wrong product in box". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0084-04
Status: Terminated
Initiated: 2003-09-16
Posted: 2003-11-01
Terminated: 2004-04-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm
Product code: KZH Introducer, Syringe Needle
Reason for recall: wrong product in box
FDA root cause: Other
Action: The recalling firm issued a recall letter to their direct customers dated 9/16/03. The recall letter explained the reason for recall and to return the product.
Quantity in commerce: 34 units
Distribution: The products were shipped to distributors in AL, AZ, CA, CO, FL, HI, IL, IN, KS, MD, MI, MN, MO, NC, NM, NY, OH, PA, TN, TX, VA, and WI. The products were shipped to government accounts in AZ, AK, DC, IN, SC, and VA. The products were shipped to hospitals nationwide.
Product codes and lots: Catalog number CC-03600, Lot number RF3066991

Product code KZH

K010399Class IIDiatek Cannon-Cath #Cc2400, Cc2800, Cc3200, Cc3600,cc5500. Cc2400pc, Cc2800pc, Cc3200pc(32 Cm), Cc3200pc(36 Cm)Diatek, Inc. / cleared 2001-08-14

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)