Z-2101-2011

Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Lot number 99767634 Multi-purpose...

Name: Z-2101-2011 Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Lot number 99767634 Multi-purpose...
Creator: Argon Medical Devices, Inc
Published: 2011-03-14
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2011-03-14 / Terminated / root cause: packaging

FDA source

Argon Medical Devices, Inc began a recall of Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Lot number 99767634 Multi-purpose Kit blister tray coupled with Tyvek lid stock... on 2011-03-14. The reason FDA records is "Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2101-2011
Status: Terminated
Initiated: 2011-03-14
Posted: 2011-04-27
Terminated: 2012-04-24
Recalling firm: Argon Medical Devices, Inc
Product: Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Lot number 99767634 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.
Product code: FTN Plastic Surgery And Accessories Kit
Reason for recall: Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Root cause tag: packaging
FDA 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 in commerce: 10 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
Product codes and lots: Lot number 99767634

Product code FTN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)