FDA Medical Device Recalls (openFDA)
Arrow International Inc: Peritoneal Lavage Kits, Model number AK-09000
- Recall number
- Z-1408-04
- Recalling firm
- Arrow International Inc
- Product
- Peritoneal Lavage Kits, Model number AK-09000
- Status
- Terminated
- Initiated
- 2004-08-02
- Posted
- 2004-08-25
- Terminated
- 2005-08-22
- Reason
- wrong introducer needle in some kits
- Root cause
- Other
- Action
- The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.
- Quantity
- 9100 units
- Distribution
- The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.
- Lot, serial or model codes
- Lot numbers: RF3111181 exp. 7/06, RF4012217 exp. 9/06, RF4012309 exp. 8/06, RF4012781 exp. 8/06, RF4023104 exp. 8/06, RF4034175 exp. 9/06, RF4034346 exp. 9/06, RF4034553 exp. 9/06, RF4055424 exp. 11/06, RF4055592 exp. 12/06, RF4055908 exp. 11/06, and RF4066874 exp. 12/06.
- 510(k) numbers
- ["K811627"]
- PMA numbers
- not on file
- Product code
- GBW
- 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