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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83857

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 15, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Western / Scott Fetzer Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Z-0339-2020
Recall number
Z-0339-2020
Initiated
August 15, 2019
Classification
Class II
Status
Terminated
Quantity
1,287 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Code information

All Lot manufactured from 08/31/14 to 08/07/2019

Distribution pattern

Worldwide distribution  US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.

device · product 2 of 5

Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Z-0340-2020
Recall number
Z-0340-2020
Initiated
August 15, 2019
Classification
Class II
Status
Terminated
Quantity
143,164 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Code information

All Lot manufactured from 08/31/14 to 08/07/2019

Distribution pattern

Worldwide distribution  US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.

device · product 3 of 5

Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Z-0341-2020
Recall number
Z-0341-2020
Initiated
August 15, 2019
Classification
Class II
Status
Terminated
Quantity
6,790 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Code information

All Lot manufactured from 08/31/14 to 08/07/2019

Distribution pattern

Worldwide distribution  US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.

device · product 4 of 5

Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Z-0342-2020
Recall number
Z-0342-2020
Initiated
August 15, 2019
Classification
Class II
Status
Terminated
Quantity
25,840 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Code information

All Lot manufactured from 08/31/14 to 08/07/2019

Distribution pattern

Worldwide distribution  US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.

device · product 5 of 5

Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Z-0343-2020
Recall number
Z-0343-2020
Initiated
August 15, 2019
Classification
Class II
Status
Terminated
Quantity
486 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Code information

All Lot manufactured from 08/31/14 to 08/07/2019

Distribution pattern

Worldwide distribution  US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.