Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Prod
FDA device recall Z-0740-2014 · posted 2014-01-14 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Action taken
- Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line. International Distributors. International distributors provided with the Recall Authorization' package and the customer letter. Accounts are requested to complete the Recall Reply Form acknowledging receipt of the notification. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 42,699 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
- Date initiated
- 2013-11-19
- Date posted
- 2014-01-14
- Date terminated
- 2015-06-11
- Location
- Hudson, NH
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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 |