The Recall Desk
HighFDA (Devices)·Z-0018-2013·Announced 2012-10-17

Accutron Recalls Ultra PC Cabinet Mount Packages Due to Flowmeter Defect

Accutron is recalling 220 Ultra PC Cabinet Mount Packages because the flowmeter may function incorrectly when nitrous gas flows without oxygen.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that could lead to improper gas delivery, representing a risk-of-harm product where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

Accutron Inc is recalling 220 units of Ultra PC Cabinet Mount Packages (Models #36600, #36800, #36600-NS, and #36800-NS) distributed nationwide in the United States. The affected products are conscious sedation units and analgesia gas machines.

The recall was initiated because the flowmeter in these devices may function in an incorrect manner when nitrous gas flows without oxygen gas being turned on. This defect poses a risk to patients using the equipment for sedation or analgesia.

Healthcare providers and consumers should stop using the affected units immediately. Accutron Inc is the recalling firm responsible for addressing this safety issue.

The recalled product

Product
Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642, 136
Manufacturer
Accutron Inc
Category
Medical Device — Anesthesia / Sedation Equipment
Hazard
Affected units
220

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model #36600
  • Lot # 73778
  • 73740
  • 73851
  • 73920
  • 74475
  • 74035
  • 74012
  • 74219
  • 74118
  • 74471
  • 75583
  • 74372
  • 75049
  • 74745
  • 75283
  • 75616
  • 75299
  • 74926
  • 75767

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Accutron Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Accutron Inc

See all →