Atrium Express Dry Seal Chest Drain ATS Blood Recovery… recallZ-1959-2014 · Atrium Medical Corporation · initiated Apr 28, 2014
Class II Terminated All recalls posted in July 2014
Is my device affected?
- 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.
- 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.
- 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
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1959-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 28, 2014
- Posted by the FDA
- Jul 1, 2014
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 195 Cases; Total 1170 units
- Product code
- CAC
- FDA submissions
- K043140, K043582
- Distribution
- Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
Product description
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Code information (models, lots, serial numbers)
Lot Number: 10906458
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.
- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OCEAN 2002-300Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall10 reports
- OCEAN 2012-320Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 reports
- OASIS 3620-100Atrium Medical Corporation · Bottle, Collection, Vacuum51 reports
- OCEAN 2002-100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall0 reports
- OCEAN 2002-040Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall0 reports
- OCEAN 2020-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM32 reports
- OASIS 3612-400Atrium Medical Corporation · Bottle, Collection, Vacuum3 reports
- OCEAN 2020-100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 report
- OCEAN 2050-300Atrium Medical Corporation · Apparatus, Autotransfusion1 report
- OASIS 3600-150Atrium Medical Corporation · APPARATUS, AUTOTRANSFUSION1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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