Recall Z-1079-2013— Thermo Fisher Scientific (Asheville) LLC
Class II · Terminated
Class II FDA medical device recall by Thermo Fisher Scientific (Asheville) LLC, initiated 2012-11-29, terminated 2015-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.. Reason: Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field..
- Recalling firm
- Thermo Fisher Scientific (Asheville) LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-29
- Terminated
- 2015-04-14
- Firm location
- Marietta, OH, United States
Product description
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.
Reason for recall
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Data sourced from openFDA. This site is unofficial and independent of the FDA.