Recall Z-2461-2012
Invacare Corporation · initiated August 6, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Invacare 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.
Codes / lots: 9780, 9781, 9781-1
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: Device Design
Action taken
Invacare 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.
Details
- Recall number
- Z-2461-2012
- Initiated
- August 6, 2012
- Posted by FDA
- September 26, 2012
- Terminated
- February 11, 2014
- Product code
- KMN – Chair And Table, Medical
- Quantity
- 21,168 chairs
- Distribution
- Worldwide 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.
- Recalling firm
- Invacare Corporation, Elyria, OH