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U.S. Department of Health and Human Services

Class 2 Device Recall IFit" Shower Chair

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 Class 2 Device Recall IFit" Shower Chairsee related information
Date Initiated by FirmAugust 06, 2012
Date PostedSeptember 26, 2012
Recall Status1 Terminated 3 on February 11, 2014
Recall NumberZ-2461-2012
Recall Event ID 62965
Product Classification Chair and table, medical - Product Code KMN
ProductInvacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
Code Information 9780, 9781, 9781-1
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
Elyria OH 44035-4190
For Additional Information ContactDouglas J. Uelmen
440-329-6619
Manufacturer Reason
for Recall		On August 6, 2012, Invacare voluntarily recalled the Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.
FDA Determined
Cause 2		Device Design
ActionInvacare sent an "URGENT: RECALL INFORMATION" letter dated August 31, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of any affected product and to call the Recall Support Line at 877-496-5041 for assistance.
Quantity in Commerce21,168 chairs
DistributionWorldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of AUSTRALIA, CANADA, GUAM, ISRAEL, NEW ZEALAND, THAILAND, TRINIDAD AND TOBAGO.
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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