| Class 2 Device Recall ARTERIAL LINE KIT | |
Date Initiated by Firm | March 29, 2010 |
Date Posted | June 02, 2010 |
Recall Status1 |
Terminated 3 on July 29, 2010 |
Recall Number | Z-1740-2010 |
Recall Event ID |
55234 |
510(K)Number | K780871 |
Product Classification |
Gauze/sponge, internal, x-ray detectable - Product Code GDY
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Product | ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. |
Code Information |
Catalog Number: 498104, Lot Number: 99737777, Expiration Date: 2014-12. |
Recalling Firm/ Manufacturer |
Argon Medical Devices, Inc 1445 Flat Creek Rd Athens TX 75751
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For Additional Information Contact | Andrea Wieczor 903-677-9375 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GDY
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