DeVilbiss Model 7305P-D Powered Suction Unit
FDA Recall Z-2246-2016 · Posted 2016-07-20
Recalling FirmDeVilbiss Healthcare LLC
Recall StatusTerminated
Product CodeJCX
Date Initiated2016-05-23
Date Terminated2017-05-30
Product Quantity48 units
Reason for Recall
A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.