Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab Tough & Tilt (

FDA device recall Z-0866-2012 · posted 2012-01-25 · Terminated

Recall details

Recalling firm

Gunnell, Inc.

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.

Action taken

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 andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.

Root cause

Component design/selection

Status

Terminated

Product code

IOR

Quantity affected

10 units

Distribution

Worldwide Distribution - USA (nationwide) nad the countries of: Australia and Canada

Date initiated

2011-11-01

Date posted

2012-01-25

Date terminated

2013-08-29

Location

Millington, MI