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CM Flowmeter Pkg H, Model #36700, Serial # recallZ-0019-2013 · Accutron Inc · initiated Apr 29, 2012

Class I Terminated All recalls posted in October 2012

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 Accutron Inc 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

Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.

FDA root cause category: Device Design

What the company is doing

Accutron sent an Urgent Advisory Notice letter dated April 6, 2012 to all their customers who purchased the Ultra PC% Cabinet Mount Flowmeter. The letter informed the customers of the problem identified and actions to be taken. Customers were instructed to discontinue use or to continue use of the device only with extreme care until a replacement can be installed. Extreme care includes the use of the titration method for nitrous oxide administration coupled with close monitoring of both the patient and the actual gas flow through the flowtubes. For question contact Accutron at (800) 531-2221 or by email at [email protected].

Recall details

Recall number
Z-0019-2013
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Apr 29, 2012
Posted by the FDA
Oct 9, 2012
Recalling firm
Accutron Inc
Quantity
220 units total
Product code
BSZ
FDA submissions
K052335
Distribution
US Nationwide Distribution

Product description

CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.

Code information (models, lots, serial numbers)

Lot # 75285

Other devices under the same FDA submission

8 devices cleared under K052335 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 63174).

Sources and updates

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