Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1211-06

ValueLine Space-Saver Folding Mat Platform model C9222-30S; C2230S

Performance Health Supply / initiated 2006-01-25 / Terminated

SAMMONS PRESTON ROLYAN began a recall of ValueLine Space-Saver Folding Mat Platform model C9222-30S; C2230S on . The reason FDA records is "There have been reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1211-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Performance Health Supply
Product
ValueLine Space-Saver Folding Mat Platform model C9222-30S; C2230S
Product code
INT Plinth
Reason for recall
There have been reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
FDA root cause
Other
Action
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
Quantity in commerce
23 devices total
Distribution
Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.
Product codes and lots
Serial number prefixess 2509 throuth 2511