Z-1630-2014 Class II Terminated
FDA device recall Z-1630-2014 was initiated by SCM True Air Technologies LLC on March 18, 2014 and is designated Class II. 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. The recall status is terminated (terminated June 11, 2018). Affected quantity: 24 beds.
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2014
- Initiation Date
- March 18, 2014
- Termination Date
- June 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 beds
Product Description
JK Bariatric Beds, True Air Technologies, Inc.
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.
Distribution Pattern
Nationwide Distribution including GA, KY, and MI.
Code Information
Serial #'s 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100, BB111, 00284A, 2171269, 62383, 4731, 4732, 4733, 4734, 4735