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U.S. Department of Health and Human Services

Class 2 Device Recall Grab n Go Opti

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  Class 2 Device Recall Grab n Go Opti see related information
Date Initiated by Firm August 15, 2019
Create Date November 06, 2019
Recall Status1 Terminated 3 on November 18, 2020
Recall Number Z-0343-2020
Recall Event ID 83857
510(K)Number K142149  
Product Classification Cylinder, compressed gas, and valve - Product Code ECX
Product 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.
Code Information All Lot manufactured from 08/31/14 to 08/07/2019
Recalling Firm/
Manufacturer		 Western / Scott Fetzer Company
875 Bassett Rd
Westlake OH 44145-1142
For Additional Information Contact Ruth McDermott
440-872-6442
Manufacturer Reason
for Recall		 Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
FDA Determined
Cause 2		 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 486 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ECX and Original Applicant = WESTERN/SCOTT FETZER CO.
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