DeVilbiss Healthcare LLC Recalls
Showing 1-3 of 3 recalls
DeVilbiss Model 7305P-D Powered Suction Unit
A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
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.
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".
DeVilbiss Healthcare sent an Urgent: Medical Device Correction notice dated May 13, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. What to do if you have an affected DV5x Series CPAP unit: 1. Verify your inventory of DV5x Series CPAPs and isolate any units that are on the included serial number list, these units will need to have the serial number corrected. 2. Please contact DeVilbiss Healthcare Customer Service to either request a Sales Representative to correct the issue on site or return the unit back to DeVilbiss to be corrected. 3. If you have already distributed any DV5x Series CPAPs included in this serial number list to end users, a patient communication has been included with this notification - a. Insert your contact information at the bottom of the "User Medical Device Correction Letter" included in this notice. b. Forward a copy of the "User Medical Device Correction Letter'' to each user to whom you have provided an affected DV5x Series CPAP unit. If you have one or more of the affected DV5x Series CPAP unit in your possession (as identified in the serial number list) and have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800- 338-1988 from 8:00AM-5:00PM EST. [Note: If you have already spoken with a DeVilbiss Healthcare Representative about this issue, there is no need to call unless you have further questions.]
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.
DeVilbiss Healthcare sent End users a field corrective action letter dated March 7, 2013, to all affected customers to reinforce the proper cleaning method. This letter is to inform you that we have come across cases where end users had exposed the bacterial filter cartridge in the disposable suction container to fluid, thereby occluding the filter and rendering it unusable Specifically what do you have to do when you receive a correction/recall notice? " The US FDA states in its correction/recall regulations that: "Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees." "Enclosed you will find two Urgent Medical Device Correction letters addressed to DeVilbiss Dealer/Provider" and "DeVilbiss User" that we ask you read carefully. "It is important that you follow the actions outlined in these letters to ensure we can effectively disseminate this information to end-users. "To reach your direct accounts we ask that you send a copy of the "DeVilbiss User" letter to each of these end-users. We sincerely appreciate all of your efforts to ensure the safety of your customers that depend on DeVilbiss products. We thank you in advance for your assistance and apologize for any inconvenience that you may experience as a result of this situation. Should you have any questions or concerns, please contact DeVilbiss Healthcare Customer Service at 1-800-338-1988.