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U.S. Department of Health and Human Services

Class 2 Device Recall Bath Safe Adjustable Shower Seat Without Back and Arms

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  Class 2 Device Recall Bath Safe Adjustable Shower Seat Without Back and Arms see related information
Date Initiated by Firm July 09, 2009
Date Posted December 01, 2009
Recall Status1 Terminated 3 on May 29, 2013
Recall Number Z-0459-2010
Recall Event ID 53161
Product Classification Transfer Aid - Product Code IKX
Product Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001
Code Information Device is not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 are being recalled.
Recalling Firm/
Manufacturer		 Nutech Manufacturing Corp
2024 Broad Street
PO Box 840
Pocomoke City MD 21851-0840
For Additional Information Contact Customer Service
800-443-4926
Manufacturer Reason
for Recall		 Safety chair used in shower/bath may not meet specifications for weight load.
FDA Determined
Cause 2		 Device Design
Action The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.
Quantity in Commerce 3,627 total units
Distribution Worldwide Distribution -- USA and Canada.
Total Product Life Cycle TPLC 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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