FDA Medical Device Recalls (openFDA)
Arrow International Inc: 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
- Recall number
- Z-0088-04
- Recalling firm
- Arrow International Inc
- Product
- 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
- Status
- Terminated
- Initiated
- 2003-10-22
- Posted
- 2003-11-01
- Terminated
- 2004-04-05
- Reason
- package lid identifies the contents incorrectly
- 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
- 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
- Lot, serial or model codes
- Catalog/Model number CL-07011, Lot number CF03075226
- 510(k) numbers
- ["K924607"]
- PMA numbers
- not on file
- Product code
- KZH
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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