FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
- Recall number
- Z-1653-2009
- Recalling firm
- Arrow International Inc
- Product
- Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
- Status
- Terminated
- Initiated
- 2009-06-17
- Posted
- 2009-07-07
- Terminated
- 2009-12-03
- Reason
- The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.
- Root cause
- Process design
- Action
- Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.
- Quantity
- 3019 units
- Distribution
- Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.
- Lot, serial or model codes
- Catalog number: CS-14502, Lot numbers: RF7019488 and RF7029944.
- 510(k) numbers
- ["K862056"]
- 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