Recall Z-0500-2007 ยท CAC Apparatus, Autotransfusion
Atrium Medical Corporation
Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
| Date | Feb 15, 2007 (initiated Nov 8, 2006) |
| Status | Terminated |
| Reason | Chest drainage tubing incorrectly assembled and may disconnect from patient during use |
| Root cause | Other |
| Action | Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned. |
| Quantity | 49 cases ( 294 units) |
| Distribution | Nationwide, including CA, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043140 | EXPRESS AND OASIS CHEST DRAIN Atrium Medical Corp., Dec 8, 2004 |