FDA Medical Device Recalls (openFDA)
Arrow International Inc: Radial Artery Catheterization Kit; Model: AK-04122
- Recall number
- Z-1285-2018
- Recalling firm
- Arrow International Inc
- Product
- Radial Artery Catheterization Kit; Model: AK-04122
- Status
- Terminated
- Initiated
- 2017-10-26
- Posted
- not on file
- Terminated
- 2019-12-10
- Reason
- The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- Root cause
- Nonconforming Material/Component
- Action
- Teleflex/Arrow sent a letter dated October 26th, 2017. Customers are instructed to discontinue use and quarantine any products with the affected product codes and lot numbers. There is a Recall Acknowledgment Form that is requested to be completed that will allow the return and replacement of the affected product. Consignees without affected product on hand are also asked to return the form.
- Quantity
- 570
- Distribution
- US nationwide distribution, including Puerto Rico.
- Lot, serial or model codes
- Lots: 13F16H0329, 13F17F0074, 13F17G0237; Expiration dates: October 2018 through March 2020
- 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