Z-1035-03

9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath

Name: Z-1035-03 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
Creator: Arrow International Inc
Published: 2003-07-08
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2003-07-08 / Terminated

FDA source

Arrow International Inc began a recall of 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath on 2003-07-08. The reason FDA records is "separation of sheath". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1035-03
Status: Terminated
Initiated: 2003-07-08
Posted: 2003-07-19
Terminated: 2004-09-02
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
Reason for recall: separation of sheath
FDA root cause: Other
Action: The recalling firm issued recall letters dated 7/9/03 to their accounts informing them of the problem and the need to return the product. To expedite product removal the recalling firm telephoned the accounts that received the complaint lot.
Quantity in commerce: 13442 units
Distribution: The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zealand, Poland, United Kingdom, and Belgium and subsidiaries in Germany, France, Africa, Canada, Netherlands, SPain, and Greece.
Product codes and lots: Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.

K940079Class IIArrow Percutaneous Sheath Introducer Kit Ak-07903Arrow Intl., Inc. / cleared 1994-11-30

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)