FDA Medical Device Recalls (openFDA)
Arrow International Inc: Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter
- Recall number
- Z-2492-2010
- Recalling firm
- Arrow International Inc
- Product
- Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter
- Status
- Terminated
- Initiated
- 2010-07-29
- Posted
- 2010-09-25
- Terminated
- 2012-07-05
- Reason
- Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
- Root cause
- Mixed-up of materials/components
- Action
- The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
- Quantity
- 2
- Distribution
- The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
- Lot, serial or model codes
- Product # CA-22702, Lot # RF0033779
- 510(k) numbers
- ["K820648"]
- PMA numbers
- not on file
- Product code
- DQY
- 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