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DeVilbiss Model 7305P-D Powered Suction Unit recallZ-2246-2016 · DeVilbiss Healthcare LLC · initiated May 23, 2016

Class II Terminated All recalls posted in July 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DeVilbiss Healthcare LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-2246-2016
Recall class
Class II
Status
Terminated
Initiated by the company
May 23, 2016
Posted by the FDA
Jul 20, 2016
Recalling firm
DeVilbiss Healthcare LLC
Quantity
48 units
Product code
JCX
FDA submissions
K982304
Distribution
US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC

Product description

DeVilbiss Model 7305P-D Powered Suction Unit

Code information (models, lots, serial numbers)

Serial numbers: PD465146 - PD465193

Other devices under the same FDA submission

8 devices cleared under K982304 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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