Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0460-2010

Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R

Nutech Manufacturing Corp / initiated 2009-07-09 / Terminated / root cause: design

Nutech Manufacturing Corp began a recall of Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R on . The reason FDA records is "Safety chair used in shower/bath may not meet specifications for weight load". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0460-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Nutech Manufacturing Corp
Product
Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R
Product code
IKX Aid, Transfer
Reason for recall
Safety chair used in shower/bath may not meet specifications for weight load.
Root cause tag
design
FDA root cause
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.
Product codes and lots
Device is not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 are being recalled.