| Class 2 Device Recall EZ Wider Bariatric Bed | |
Date Initiated by Firm | August 02, 2012 |
Date Posted | June 05, 2013 |
Recall Status1 |
Terminated 3 on March 02, 2018 |
Recall Number | Z-1480-2013 |
Recall Event ID |
64927 |
Product Classification |
Bariatric bed - Product Code OSI
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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 IL 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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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