Recall Z-0063-2007
Invacare Corporation · initiated September 27, 2006
Product
AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS
Codes / lots: Serial Numbers Affected : 06CF035033 06DF003462 06DF007408 06DF018274 06DF027564 06DF029581 06DF042349 06EF006839 06CF035034 06DF003483 06DF007409 06DF018275 06DF027565 06DF029582 06DF042350 06EF006840 06CF035035 06DF003484 06DF007410 06DF018276 06DF027566 06DF029583 06DF042351 06EF006841 06CF035036 06DF007274 06DF007411 06DF018277 06DF027567 06DF029584 06DF042352 06EF006842 06CF035037 06DF007275 06DF007412 06DF018278 06DF027568 06DF029585 06DF042353 06EF006843 06CF035038 06DF007276 06DF007413 06DF018279 06DF027569 06DF029586 06DF042354 06EF006844 06CF035039 06DF007277 06DF007414 06DF018280 06DF027570 06DF032354 06DF042355 06EF006845 06CF035040 06DF007278 06DF007415 06DF018281 06DF027571 06DF032355 06DF042356 06EF006846 06CF035041 06DF007279 06DF007416 06DF018282 06DF027572 06DF032356 06DF042357 06EF006847 06CF035042 06DF007280 06DF007417 06DF018283 06DF027573 06DF032357 06DF042358 06EF006848 06CF035043 06DF007281 06DF007418 06DF018284 06DF027574 06DF032358 06DF042359 06EF006849 06CF035044 06DF007282 06DF007419 06DF018285 06DF027575 06DF032359 06DF042360 06EF006850 06CF035045 06DF007283 06DF007420 06DF018286 06DF027576 06DF032360 06DF042361 06EF006851 06CF035046 06DF007284…
Reason for recall
The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).
FDA-determined cause: Other
Action taken
E-mails and letters regarding this correction provided to the consignees on September 27, 2006, and to appropriate Invacare personnel for information purposes. Consignees are being notified via delivery of a field correction package. Once the packages have been sent, a notice will be posted on the Invacare website. A follow-up contact will be scheduled in 2 to 3 months to try to reach those who have not returned their tracking sheet indicating completion of their corrective action.
Details
- Recall number
- Z-0063-2007
- Initiated
- September 27, 2006
- Posted by FDA
- October 24, 2006
- Terminated
- October 5, 2009
- Product code
- LLI – Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Quantity
- 2065
- Distribution
- United States and Canada.
- Recalling firm
- Invacare Corporation, Sanford, FL