Recall Z-1959-2014 ยท CAC Apparatus, Autotransfusion
Atrium Medical Corporation
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
| Date | Jul 1, 2014 (initiated Apr 28, 2014) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| 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. |
| Quantity | 195 Cases; Total 1170 units |
| Distribution | Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT. |
| FDA record | Open on fda.gov |