Recall Z-0342-2020 ยท ECX Cylinder, Compressed Gas, And Valve
Western / Scott Fetzer Company
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 Con
| Date | Aug 15, 2019 |
| Status | Terminated |
| Reason | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range |
| 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/plat |
| Quantity | 25,840 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142149 | OXYTOTE INFINITY SERIES VIPR SYSTEMS Western/Scott Fetzer Co., Apr 17, 2015 |