Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0084-06

HoverMatt Patient Transfer Solution/Air Transfer Mattress

D.T. Davis Enterprises Ltd. / initiated 2005-09-13 / Terminated / root cause: labeling and UDI

D.T. Davis Enterprises Ltd. began a recall of HoverMatt Patient Transfer Solution/Air Transfer Mattress on . The reason FDA records is "Instructions for use are not adhering to the product". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0084-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
D.T. Davis Enterprises Ltd.
Product
HoverMatt Patient Transfer Solution/Air Transfer Mattress
Product code
FRZ Device, Patient Transfer, Powered
Reason for recall
Instructions for use are not adhering to the product
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Recalling firm issued recall letters dated October 5, 2005 informing the hospitals of the problem and that firm representatives would contact them to visit their facilities to affix new labels.
Quantity in commerce
866 units
Distribution
Products were shipped to hospitals nationwide. Product was also shipped to Canada, Australia, and the United Kingdom.Product was shipped to government accounts in TN, PA, and CA.
Product codes and lots
Model Numbers HM28HS, HM28DC, HM34HS, HM34DC, HM39HS, HM39DC