FDAClass IIJuly 9, 2014

Atrium Express Dry Seal Chest Drain ATS Blood Recovery recall

Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.

Why was Atrium Express Dry Seal Chest Drain ATS Blood Recovery recalled?

Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.

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: 10906458

Product
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Recalling firm
Atrium Medical Corporation
Quantity
195 Cases; Total 1170 units
Distribution
Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
Recall date
July 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls