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U.S. Department of Health and Human Services

Class 2 Device Recall EZ Wider Bariatric Bed

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 Class 2 Recall
EZ Wider Bariatric Bed
see related information
Date Posted June 05, 2013
Recall Status1 Open
Recall Number Z-1480-2013
Recall Event ID 64927
Product Classification Bariatric Bed - Product Code OSI
Product E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
Code Information Models ASM100100 and ASM100104; Lot 1 (Blue Beds) Serian Numbers: KM100101, KM100102, KM100103, KM100104, KM100105, KM100106, KM100107, KM100108, KM100209, KM100100; Lot 2 (White Beds) Serial Numbers: KM100109, KM100111, KM100112, KM100113, KM100114, KM100115, KM100116, KM100117, KM100118, KM100119, KM100120; Lot 3 (White Beds) Serial Numbers: KM100144, KM100145, KM100146, KM100147, KM100148, KM100149, KM100150, KM100151, KM100152, KM100153, KM100154, KM100155, KM100156, KM100156, KM100157, KM1000158; Lot 4: (White Beds) Serial Numbers: KM100194, KM100195, KM100196, KM100197, KM100198, KM100199, KM100200, KM100201, KM100202, KM100203, KM100204, KM100205, KM100206, KM100207, KM100208; Lot 5: (White Beds) Serial Numbers: KM100211, KM100212, KM100213, KM100214, KM100215, KM100216, KM100217, KM100218
Recalling Firm/
Manufacturer
Kreg Medical Inc.
2240 W Walnut St
Chicago, Illinois 60612-2218
For Additional Information Contact Mr. Craig Poulos
312-275-7070
Manufacturer Reason
for Recall
An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.
FDA Determined
Cause 2
DESIGN: Device Design
Action Kreg Medical sent an Urgent Voluntary Medical Device Recall letter dated May 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Kreg Medical started replacing potentially defective beds with refurbished beds in August 2012. All of the potentiall defective beds were refurbished by November 20, 2012. Customers were requested to send back the Medical Device Recall Return Response to confirm receipt of the notification letter. For questions regarding this recall call 312-275-7070.
Quantity in Commerce 59 beds
Distribution Nationwide Distribution including IL and IN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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