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