Recall Z-0740-2014
Atrium Medical Corporation · initiated November 19, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
Codes / lots: Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
Reason for recall
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0740-2014
- Initiated
- November 19, 2013
- Posted by FDA
- January 14, 2014
- Terminated
- June 11, 2015
- Product code
- CAC – Apparatus, Autotransfusion
- Quantity
- 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.
- Recalling firm
- Atrium Medical Corporation, Hudson, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0735-2014 Class II | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | 11/19/2013Terminated |
| Z-0736-2014 Class II | Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | 11/19/2013Terminated |
| Z-0737-2014 Class II | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | 11/19/2013Terminated |
| Z-0738-2014 Class II | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | 11/19/2013Terminated |
| Z-0739-2014 Class II | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | 11/19/2013Terminated |
| Z-0741-2014 Class II | Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | 11/19/2013Terminated |
| Z-0742-2014 Class II | Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | 11/19/2013Terminated |
| Z-0743-2014 Class II | Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | 11/19/2013Terminated |