Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
FDA Recall Z-0863-2012 · Posted 2012-01-25
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Recalling FirmGunnell, Inc.
Recall StatusTerminated
Product CodeIOR
Date Initiated2011-11-01
Date Terminated2013-08-29
Product Quantity23 (22 listed)
Reason for Recall
Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt (TNT), Bariatric Rehab Tough and Tilt (BTNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Recline and Mobility (BRAM), and Rehab Kidster.
Firm Action
Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to [email protected]. or call 1-800-551-0055, attention Andy Evancho.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - USA (nationwide) nad the countries of: Australia and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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