—#90510

Product

CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx.. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

FDA product code: DRE — Dilator, Vessel, For Percutaneous Catheterization
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K781333
Affected lot / code info: Catalog Number: 496185, Lot Number: 99738261, Expiration Date: 2014-07.

Why it was recalled

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 (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751

Distribution

Distribution pattern: Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.

Timeline

Recall initiated: 2010-03-29
Posted by FDA: 2010-06-02
Terminated: 2010-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90510. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.