Recall Z-1079-2013 ยท JTQ Bath, Incubators/Water, All
Thermo Fisher Scientific (Asheville) LLC
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.
| Date | Apr 10, 2013 (initiated Nov 29, 2012) |
| Status | Terminated |
| Reason | Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field. |
| Root cause | Component design/selection |
| Action | Thermo Fisher sent an Urgent Field Correction Notice letter dated November 19, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate all affected products and determine if it is within the recall. If so, they are to return the Acknowledgement Form in order to get replacement hinges and instructions. Upon receipt of the new hinges they are to replace them according to the instructions. |
| Quantity | 15,567 incubators |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANIST |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.