Z-0088-04

10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set

Name: Z-0088-04 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
Creator: Arrow International Inc
Published: 2003-10-22
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2003-10-22 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set on 2003-10-22. The reason FDA records is "package lid identifies the contents incorrectly". 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-0088-04
Status: Terminated
Initiated: 2003-10-22
Posted: 2003-11-01
Terminated: 2004-04-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
Product code: KZH Introducer, Syringe Needle
Reason for recall: package lid identifies the contents incorrectly
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.
Quantity in commerce: 80 units
Distribution: The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka
Product codes and lots: Catalog/Model number CL-07011, Lot number CF03075226

Product code KZH

K924607Class IIArrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. / cleared 1993-04-22

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)