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U.S. Department of Health and Human Services

Class 2 Device Recall Norco Folding Shower Bench

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 Class 2 Device Recall Norco Folding Shower Benchsee related information
Date Initiated by FirmMarch 20, 2012
Date PostedApril 16, 2012
Recall Status1 Terminated 3 on July 20, 2012
Recall NumberZ-1429-2012
Recall Event ID 61455
Product Classification Aid, transfer - Product Code IKX
ProductNorco 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
Code Information Model NC87102, all units.
FEI Number 1000124207
Recalling Firm/
Manufacturer		 North Coast Medical Inc
8100 Camino Arroyo
Gilroy CA 95020-7304
For Additional Information ContactCheri Koehler
800-821-9319 Ext. 121
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionNorth 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 Commerce370 benches
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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