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Terminated

Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251.

FDA Recall Z-0648-2009 · Posted 2009-02-04

Recall StatusTerminated
Product CodeFPP
Date Initiated2008-11-18
Date Terminated2010-10-27
Product Quantity6

Reason for Recall

Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.

Firm Action

Consignees were notified by Urgent Medical Device Correction letter dated 11/18/08 and given the serial numbers of their units, an upgrade kit and instructions for performing replacement of the bolts. Consignees were informed Stryker will perform the upgrade if requested.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution: USA, India, Netherlands and United Kingdom.

Official Source

View FDA Recall →

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

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