Recall Z-1632-2014 ยท FNM Mattress, Air Flotation, Alternating Pressure
SCM True Air Technologies LLC
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
| Date | May 19, 2014 (initiated Mar 18, 2014) |
| Status | Terminated |
| Reason | The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. |
| Root cause | Nonconforming Material/Component |
| Action | SCM True Air Technologies LLC sent an Urgent Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from use and return to True Air Technologies immediately. The units should be decontaminated and bagged with a certification of disinfection before return to True Air Technologies. True Air will provide replacement units to replace the returned units. Customers were instructed to refer to the Medical Device Recall Return Response Form attached |
| Quantity | 83 units |
| Distribution | Nationwide Distribution including GA, KY, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.