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ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE… recallZ-1742-2010 · Argon Medical Devices, Inc · initiated Mar 29, 2010

Terminated All recalls posted in June 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Package design/selection

What the company is doing

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.

Recall details

Recall number
Z-1742-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 29, 2010
Posted by the FDA
Jun 2, 2010
Recalling firm
Argon Medical Devices, Inc
Quantity
121 kits
Product code
KGC
FDA submissions
K780871
Distribution
Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.

Product description

ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

Code information (models, lots, serial numbers)

Catalog Number: 498411B, Lot Number: 99736745, Expiration Date: 2012-10.

Other devices under the same FDA submission

7 devices cleared under K780871 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 55234).

Sources and updates

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