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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1480-2013 | Class II | Terminated | Voluntary: Firm initiated |
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