Medical Device
Manufacturing
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Z-1429-2012

Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess...

North Coast Medical Inc / initiated 2012-03-20 / Terminated / root cause: design

North Coast Medical Inc began a recall of Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have... on . The reason FDA records is "Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a force greater than 150 lbs". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1429-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
North Coast Medical Inc
Product
Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. North Coast Medical Inc. 8100 Camino Arroyo Gilroy, CA 95020 Comfort and safety in shower
Product code
IKX Aid, Transfer
Reason for recall
Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a force greater than 150 lbs.
Root cause tag
design
FDA root cause
Device Design
Action
North Coast Medical, Inc. sent a Recall Notification Letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and discard the affected product. Complete the enclosed Form and return the form even if they no longer have the bath bench. Return the form by fax to 408-775-1430. Customers should contact the Quality Department if they have any questions, concerns or need any assistance following the instructions. For questions regarding this recall call 800-821-9319, ext 121.
Quantity in commerce
370 benches
Distribution
Nationwide Distribution
Product codes and lots
Model NC87102, all units.