DeVilbiss Model 7305P-D Powered Suction Unit
FDA device recall Z-2246-2016 · posted 2016-07-20 · Terminated
Recall details
- Recalling firm
- DeVilbiss Healthcare LLC
- Reason for recall
- A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JCX
- Quantity affected
- 48 units
- Distribution
- US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC
- Date initiated
- 2016-05-23
- Date posted
- 2016-07-20
- Date terminated
- 2017-05-30
- Location
- Somerset, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEVILBISS SUCTION UNIT (K982304) | Sunrise Medical Hhg, Inc. | 1998-09-25 |