Recall Z-2246-2016 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
DeVilbiss Healthcare LLC
DeVilbiss Model 7305P-D Powered Suction Unit
| Date | Jul 20, 2016 (initiated May 23, 2016) |
| Status | Terminated |
| Reason | A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 48 units |
| Distribution | US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982304 | DEVILBISS SUCTION UNIT Sunrise Medical Hhg, Inc., Sep 25, 1998 |