Recalls / —
—#127513
Product
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
- FDA product code
- CAC — Apparatus, Autotransfusion
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K043140, K043582
- Affected lot / code info
- Lot Number: 10906458
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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Atrium Medical Corporation
- Address
- 5 Wentworth Dr, Hudson, New Hampshire 03051-4929
Distribution
- Distribution pattern
- Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
Timeline
- Recall initiated
- 2014-04-28
- Posted by FDA
- 2014-07-01
- Terminated
- 2016-03-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #127513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.