Reported Jul 29, 2015 · Terminated

Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product…

Western / Scott Fetzer Company

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Western / Scott Fetzer Company · 875 Bassett Rd · Westlake, OH · 44145-1142

Is this the product you have?

  • Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package
  • Product UsageUsed to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen
Lot codes and dates

47 of 47 products

Products covered by this recall
#Product as published
1The recall affects all lot numbers (made prior to 10/01/2014) for the following Model Numbers: AAG-403
2AAG-800
3AAG-802
4AAG-803
5GTS-303
6GTS-4206
7GTS-600
8GTS-603
9JHR-900
10JHR-LG-MTS-903
11LAW-603
12MNR-3000
13MNR-600
14MNR-800
15MNS-602
16MNS-603
17MNS-803
18MNS-C803
19MTR-100
20MTR-300
Amount recalled
162,678 units

Where it was sold

Why it was recalled

Stop using this product now

The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 18, 2018 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.