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U.S. Department of Health and Human Services

Class 2 Device Recall Bath Safe Adjustable Shower Seat With Back

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 Class 2 Device Recall Bath Safe Adjustable Shower Seat With Backsee related information
Date Initiated by FirmJuly 09, 2009
Date PostedDecember 01, 2009
Recall Status1 Terminated 3 on May 29, 2013
Recall NumberZ-0461-2010
Recall Event ID 53161
Product Classification Transfer Aid - Product Code IKX
ProductBath Safe Adjustable Shower Seat, With Back, Catalog number 727142101
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 ContactCustomer 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
ActionThe 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 Commerce3,627 total units
DistributionWorldwide Distribution -- USA and Canada.
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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