FDAClass IIMay 28, 2014

JK Bariatric Beds recall

JK Bariatric Beds, True Air Technologies, Inc.

Why was JK Bariatric Beds recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
JK Bariatric Beds, True Air Technologies, Inc.
Recalling firm
SCM True Air Technologies LLC
Quantity
24 beds
Distribution
Nationwide Distribution including GA, KY, and MI.
Recall date
May 28, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls