Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0174-04

Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak

Invacare GmbH / initiated 2003-06-09 / Terminated

Invacare Corporation began a recall of Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak on . The reason FDA records is "Pull tube on bed may bend or separate causing inoperability of bed or head section to fall". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0174-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.
Product code
LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Reason for recall
Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.
FDA root cause
Other
Action
The firm began telephoning direct consignees on 6/9/03 and also began sending recall letters to these consignees on 6/9/03. The letter provides a list of affected units shipped to the consignee and the serial number of the affected foot section on the bed. If the consignee indicated they wanted to perform the correction themselves then the indicated number of corrective bracket installation kits are being sent. Also they are given the option of having an Invacare authorized service center perform the correction. This is for units in their possession and also at patient homes. As of October 2003 enough corrective kits have been forwarded to dealers to correct all involved units.
Quantity in commerce
5926
Distribution
involved products were distributed to approximately 1100 dealers in the United Stated and to 54 Canadian dealer accounts.
Product codes and lots
Foot section model numbers and serial number ranges: Model # Beginning S/N Ending S/N 5490IVC 03D891256 03E035155 5890IVC 03D889942 03E002241 5491IVC 03E969254 03E433379 5891IVC 03E970154 03E971163  Bed Models that include the recalled food sections: 5310IVC, 5311IVC, 5410IVC, 5411IVC  Bed package model numbers which include the affected Beds and foot sections:  BED-21VC, BED-4IVC, BED-9IVC, BED-10IVC, BED-19IVC, BED-21IVC, BED-22IVC, BED-23IVC, BED-24IVC, BED-25IVC, BED-26IVC, BED-27IVC, BED-28IVC, BED-29IVC, BED-32IVC, BED-33IVC, BED-34IVC, BED-35IVC, BED-36IVC, BED-37IVC, CBED-2IVC, CBED-4IVC, CBED-4BIVC, CBED-11IVC, CBED-11BIVC, CBED-12IVC, CBED-12BIVC, CBED-19IVC, CBED-22IVC, CBED-23IVC, CBED-26IVC, CBED-28IVC.