FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
- Recall number
- Z-1965-2013
- Recalling firm
- Arrow International Inc
- Product
- Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
- Status
- Terminated
- Initiated
- 2013-07-31
- Posted
- 2013-08-14
- Terminated
- 2015-04-28
- Reason
- Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
- Root cause
- Labeling Change Control
- Action
- An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.
- Quantity
- 156
- Distribution
- AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
- Lot, serial or model codes
- Catalog # AK-17702-CDC, lot # RF2083258
- 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