FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
- Recall number
- Z-2274-2010
- Recalling firm
- Arrow International Inc
- Product
- Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
- Status
- Terminated
- Initiated
- 2010-06-07
- Posted
- 2010-08-25
- Terminated
- 2012-09-29
- Reason
- Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.
- Root cause
- Process change control
- Action
- June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.
- Quantity
- 3000 kits
- Distribution
- All affected product was distributed to one foreign consignee: Arrow Japan Ltd.
- Lot, serial or model codes
- Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
- 510(k) numbers
- ["K781846"]
- PMA numbers
- not on file
- Product code
- KGZ
- 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