FDA Device recall Z-2069-2015
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package
- FDA Device
- Class I
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class I recall of Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package by Western Scott Fetzer, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2069-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-01-31 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Western Scott Fetzer |
| Distribution | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used 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.
Reason
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.
Identifiers
| code_info | The recall affects all lot numbers (made prior to 10/01/2014) for the following Model Numbers: AAG-403; AAG-800; AAG-…The recall affects all lot numbers (made prior to 10/01/2014) for the following Model Numbers: AAG-403; AAG-800; AAG-802; AAG-803; GTS-303; GTS-4206; GTS-600; GTS-603; JHR-900; JHR-LG-MTS-903; LAW-603; MNR-3000; MNR-600; MNR-800; MNS-602; MNS-603;; MNS-803; MNS-C803; MTR-100; MTR-300; MTR-500; MTR-600; MTR-700; MTR-800; MTS-303; MTS-403; MTS-501; MTS-502; MTS-503; MTS-505; MTS-601; MTS-602; MTS-603; MTS-803; OXC-503; PHS-LG-MTS-803; ROC-9792; ROC-9793; RRI-500; RRI-600; TRI-803; VLB-603; VLB-603H; VNG-600; VNG-603; VNG-800; and WOX-603. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2069-2015%22
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