Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1480-2013Class II

E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

Kreg Medical Inc. / initiated 2012-08-02 / Terminated / root cause: design

Kreg Medical Inc. began a recall of E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology on . FDA classified it as Class II and gives the reason as "An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1480-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Kreg Medical Inc.
Product
E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
Product code
OSI Bariatric Bed
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.
Root cause tag
design
FDA root cause
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1480-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1480-2013Class IITerminatedVoluntary: Firm initiated