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Terminated

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

FDA Recall Z-1959-2014 · Posted 2014-07-01

Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2014-04-28
Date Terminated2016-03-17
Product Quantity195 Cases; Total 1170 units

Reason for Recall

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.

Firm Action

Smith & Nephew notified Distributors on April 28, 2014 by telephone. A follow up e-mail and a recall notification letter were issued by UPS on 6/27/14. Distributors were requested to notify customers who received the lot. A reply acknowledgement form was to be completed and returned. Return Goods Authorizations for the return of the goods were issued to customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043582OCEAN CHEST DRAINAtrium Medical Corp. · 2005-01-21K043140EXPRESS AND OASIS CHEST DRAINAtrium Medical Corp. · 2004-12-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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