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Terminated

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

FDA Recall Z-1480-2013 · Posted 2013-06-05

Recalling FirmKreg Medical Inc.
Recall StatusTerminated
Product CodeOSI
Date Initiated2012-08-02
Date Terminated2018-03-02
Product Quantity59 beds

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution including IL and IN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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