FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
- Recall number
- Z-2327-2017
- Recalling firm
- Arrow International Inc
- Product
- Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
- Status
- Terminated
- Initiated
- 2017-05-09
- Posted
- not on file
- Terminated
- 2018-09-17
- Reason
- Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Root cause
- Packaging
- Action
- Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
- Quantity
- 27, 485 distributed in the U.S, 4,371 distributed Internationally
- Distribution
- Worldwide Distribution - US (nationwide) and Canada
- Lot, serial or model codes
- Material number: ASK-04018-CC, ASK-04510-HUM, ASK-04550-UHC, Device Listing D025180
- 510(k) numbers
- ["K810675"]
- PMA numbers
- not on file
- Product code
- DQX
- 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