FDAClass IIJanuary 22, 2014

Atrium Express Dry Seal ATS recall

Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest…

Why was Atrium Express Dry Seal ATS recalled?

Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)

Product
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest…
Recalling firm
Atrium Medical Corporation
Quantity
7,274 units
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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