Recall Z-0318-2024 ยท CAC Apparatus, Autotransfusion
Atrium Medical Corporation
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
| Date | Nov 16, 2023 (initiated Sep 18, 2023) |
| Status | Open, Classified |
| Reason | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains |
| Root cause | Error in labeling |
| Action | UPDATE: April 2024. Getinge issued letter Getinge Thoracic Drainage Labeling Updates: New Instructions for Use Precaution for Oasis and Express Chest Drains to existing customers April 17, 2024 (US) and April 23, 2024 (OUS). As a result, inventory will be a mix of the current IFU and new IFU with the updated precaution statement until the current IFU-containing products are depleted. Reminder: In September 2023, Getinge initiated Medical Device Correction 3011175548-08/18/2023-001-C which requested your facility to post a copy of the Notice on Page 4 of the notification in all inventory loca |
| Quantity | 48339 cases: 48148 cases US; 193 cases OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Republic of Kuw |
| FDA record | Open on fda.gov |