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 Recall Z-1738-2010 · Posted 2010-06-02
Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDRE
Date Initiated2010-03-29
Date Terminated2010-07-29
Product Quantity10 kits
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.
Firm 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.
Root Cause
Package design/selection
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.