ARTERIAL LINE KIT REF/REORDER NO. 498410B DISPOSABLE, SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
This recall has been terminated (originally issued June 2, 2010).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- March 29, 2010
- Posted
- June 2, 2010
- Terminated
- July 29, 2010
- Recall Number
- Z-1741-2010
- Quantity
- 10 kits
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 / Code Info
Catalog Number: 498410B, Lot Number: 99737665, Expiration Date: 2012-10.
Root Cause
Package design/selection
Action Taken
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.