FDA Enforcement
Class II
Terminated
DeVilbiss Model 7305P-D Powered Suction Unit
Recall: Z-2246-2016
·
Reported July 27, 2016
Enforcement
- Recall Number
- Z-2246-2016
- Event ID
- 74308
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DeVilbiss Healthcare LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 27, 2016
- Initiation Date
- May 23, 2016
- Classification Date
- July 20, 2016
- Termination Date
- May 30, 2017
- Address
- 100 Devilbiss Dr, N/A, Somerset, PA, 15501-2125, United States
Description
DeVilbiss Model 7305P-D Powered Suction Unit
Reason
A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
Code Info
Serial numbers: PD465146 - PD465193
Distribution
US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC
Quantity
48 units