Class 2 Device Recall DeVilbiss 7305PD Suction Unit

• Date Initiated by Firm: May 23, 2016
• Date Posted: July 20, 2016
• Recall Status: Terminated on May 30, 2017
• Recall Number: Z-2246-2016
• Recall Event ID: 74308
• 510(K)Number: K982304
• Product Classification: Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
• Product: DeVilbiss Model 7305P-D Powered Suction Unit
• Code Information: Serial numbers: PD465146 - PD465193
• Recalling Firm/ Manufacturer: DeVilbiss Healthcare LLC; 100 Devilbiss Dr; Somerset PA 15501-2125
• For Additional Information Contact: Betty Miller; 814-443-7602
• Manufacturer Reason for Recall: A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
• FDA Determined 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 in Commerce: 48 units
• Distribution: US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JCX