FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: Argon Medical Devices Arterial Line Kit, 20ga x 1.75", Part Number 498418, Lot number 99768059 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.
- Recall number
- Z-2094-2011
- Recalling firm
- Argon Medical Devices, Inc
- Product
- Argon Medical Devices Arterial Line Kit, 20ga x 1.75", Part Number 498418, Lot number 99768059 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.
- Status
- Terminated
- Initiated
- 2011-03-14
- Posted
- 2011-04-27
- Terminated
- 2012-04-24
- Reason
- Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
- Root cause
- Other
- Action
- Argon Medical Devices sent an Urgent Medical Device Recall letter dated March 14, 2011, by certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine and return any product remaining at their facility utilizing the instruction on the 2011 Tray Recall Response Form. Customers were instructed to complete the response form included with the letter and return by fax or email as indicated as soon as possible. Customers were instructed to pass the notice on to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. For questions regarding this recall call (903) 677-9375.
- Quantity
- 200 units
- Distribution
- Worldwide Distribution - USA including AL, AZ, CA, CO, DE, GA, HI, IL, IN, LA, MD, MN, ND, NE, NH, NJ, NY, OK, PA, SC, TX, VA, WA, and WI and the countries of Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands
- Lot, serial or model codes
- Lot number 99738059
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FTN
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- 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