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Recall Observatory FDA recall evidence

Device product

JK Bariatric Beds, True Air Technologies, Inc.

Z-1630-2014

March 18, 2014

Class II

Product summary

Firm
SCM True Air Technologies LLC
Event
Event 67924
Status
Terminated
Classification
Class II
Quantity
24 beds
Official record key
device-enforcement:Z-1630-2014

Official wording

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.

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

Distribution pattern: Nationwide Distribution including GA, KY, and MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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