FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
- Recall number
- Z-1740-2010
- Recalling firm
- Argon Medical Devices, Inc
- Product
- ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
- Status
- Terminated
- Initiated
- 2010-03-29
- Posted
- 2010-06-02
- Terminated
- 2010-07-29
- Reason
- There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
- Root cause
- Package design/selection
- Action
- Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm. For further information, contact Argon Medical Devices at 1-903-677-9375.
- Quantity
- 363 kits
- Distribution
- Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.
- Lot, serial or model codes
- Catalog Number: 498104, Lot Number: 99737777, Expiration Date: 2014-12.
- 510(k) numbers
- ["K780871"]
- PMA numbers
- not on file
- Product code
- GDY
- 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