MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

FDA device recall Z-1632-2014 · posted 2014-05-19 · Terminated

Recall details

Recalling firm

SCM True Air Technologies LLC

Reason for recall

The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

Action taken

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 for acknowledgement of receipt and contact information for this voluntary recall. Customers with questions should call 800-682-7163.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FNM

Quantity affected

83 units

Distribution

Nationwide Distribution including GA, KY, and MI.

Date initiated

2014-03-18

Date posted

2014-05-19

Date terminated

2018-06-11

Location

Louisville, KY