Z-0341-2020Class II
Grab n Go Opti series VIPR system Model # PRX-9632 -
Western Enterprises, Inc. / initiated 2019-08-15 / Terminated / root cause: design
Western / Scott Fetzer Company began a recall of 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... on . FDA classified it as Class II and gives the reason as "Limited access to flow settings as a result of the control knob having been rotated beyond its functional range". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0341-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Western Enterprises, Inc.
- Product
- 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.
- Product code
- ECX Cylinder, Compressed Gas, And Valve
- Reason for recall
- Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Western formally communicated the product issue to Praxair on 7/12/19, who had been previously in contact with Western regarding this issue. Western plans to issue a formal communication to affected distributors in the near future. The firm has initiated corrective action in the field as of August 2019. The firm has implemented a new screening process at each fill plant to identify and isolate units that could potentially be rotated past the stop. Units which fail are isolated and returned to Western, which will inspect each failed unit, replace the failed component with the revised knob/plate, and return the refurbished unit to the fill plant. One customer specifically requested that, instead of the screening procedure above, all of its units in service be replaced with the revised design. Western fulfilled this request. On October 11, 2019, Western mailed a Medical Device Recall letter to its distributors to officially communicate the issue.
- Quantity in commerce
- 6,790 units
- Distribution
- 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.
- Product codes and lots
- All Lot manufactured from 08/31/14 to 08/07/2019
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0339-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0340-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0341-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0342-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0343-2020 | Class II | Terminated | Voluntary: Firm initiated |
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