Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
FDA device recall Z-0235-2023 · posted 2022-11-15 · Open, Classified
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
- Action taken
- Atrium/ Getinge issued Urgent Medical Device Removal on 10/18/21 via email with Delivery and Read receipt. Letter states reason for recall, health risk and action to take: Our records indicate that McKesson has received the Atrium Ocean Wet Suction Water Seal Chest Drains from the lot listed on Page 1. " Please examine your inventory and confirm that you have no remaining Atrium Ocean Wet Suction Water Seal Chest Drain 2002-000 with the REF/LOT number listed in this notice. Please return any product that may be affected under this Field Action. " Please respond to this email using the response form on page 3 to acknowledge that you have received this notification. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Root cause
- Storage
- Status
- Open, Classified
- Product code
- KDQ
- Quantity affected
- 24 units (4cases/6)
- Distribution
- US Nationwide distribution in the state of VA.
- Date initiated
- 2022-10-18
- Date posted
- 2022-11-15
- Location
- Merrimack, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCEAN CHEST DRAIN (K043582) | Atrium Medical Corp. | 2005-01-21 |