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Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion)… recallZ-0740-2014 · Atrium Medical Corporation · initiated Nov 19, 2013

Class II Terminated All recalls posted in January 2014

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 Atrium Medical Corporation 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

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

FDA root cause category: Device Design

What the company is doing

Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line. International Distributors. International distributors provided with the Recall Authorization' package and the customer letter. Accounts are requested to complete the Recall Reply Form acknowledging receipt of the notification. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm.

Recall details

Recall number
Z-0740-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 19, 2013
Posted by the FDA
Jan 14, 2014
Recalling firm
Atrium Medical Corporation
Quantity
42,699 units
Product code
CAC
FDA submissions
K043140, K043582
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Product description

Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

12 devices cleared under K043140, K043582 — 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 66788).

Sources and updates

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