Atrium Express Dry Seal Chest Drain Recall Due to Leaking Risk
Atrium Medical Corporation is recalling 1,170 units of the Express Dry Seal Chest Drain ATS Blood Recovery because the tubing may leak or disconnect.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). The risk of tubing leaking or disconnecting in a medical device constitutes a significant hazard.
Plain-English summary
Atrium Medical Corporation is recalling 1,170 units of the Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number 4050-100N. This autotransfusion apparatus was previously recalled because the chest drain tubing may leak or disconnect. The product was released for distribution in error.
The affected units, identified by Lot Number 10906458, were distributed in the states of Alaska, California, Maryland, Minnesota, Missouri, North Carolina, New Jersey, Ohio, and Utah. The total quantity involved is 195 cases.
Healthcare facilities and consumers should stop using the affected product immediately. Atrium Medical Corporation is the recalling firm responsible for this action.
The recalled product
- Product
- Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
- Manufacturer
- Atrium Medical Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 10906458
Distribution
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