Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
FDA device recall Z-1959-2014 · posted 2014-07-01 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 195 Cases; Total 1170 units
- Distribution
- Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
- Date initiated
- 2014-04-28
- Date posted
- 2014-07-01
- Date terminated
- 2016-03-17
- Location
- Hudson, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCEAN CHEST DRAIN (K043582) | Atrium Medical Corp. | 2005-01-21 |
| EXPRESS AND OASIS CHEST DRAIN (K043140) | Atrium Medical Corp. | 2004-12-08 |