Recall Z-2246-2016
DeVilbiss Healthcare LLC · initiated May 23, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DeVilbiss Model 7305P-D Powered Suction Unit
Codes / lots: Serial numbers: PD465146 - PD465193
Reason for recall
A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
FDA-determined cause: Component design/selection
Action taken
DeVilbiss Healthcare sent an Urgent - Medical Device Recall letter on May 23, 2016, to all affected customers notifying them of the issue. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to isolate all of the affected units included on the serial number list and return for replacement. For further questions, please call (814) 443-7602.
Details
- Recall number
- Z-2246-2016
- Initiated
- May 23, 2016
- Posted by FDA
- July 20, 2016
- Terminated
- May 30, 2017
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Quantity
- 48 units
- Distribution
- US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC
- Recalling firm
- DeVilbiss Healthcare LLC, Somerset, PA