FDA Medical Device Recalls (openFDA)
Arrow International Inc: 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
- Recall number
- Z-1035-03
- Recalling firm
- Arrow International Inc
- Product
- 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
- Status
- Terminated
- Initiated
- 2003-07-08
- Posted
- 2003-07-19
- Terminated
- 2004-09-02
- Reason
- separation of sheath
- 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
- 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.
- Lot, serial or model codes
- Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.
- 510(k) numbers
- ["K940079"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28