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
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