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U.S. Department of Health and Human Services

Class 2 Device Recall ProNox Analgesic Gas Mixing and Delivery System

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  Class 2 Device Recall ProNox Analgesic Gas Mixing and Delivery System see related information
Date Initiated by Firm May 15, 2018
Create Date August 22, 2018
Recall Status1 Open3, Classified
Recall Number Z-2887-2018
Recall Event ID 80340
510(K)Number K113687  
Product Classification Mixer, breathing gases, anesthesia inhalation - Product Code BZR
Product CAREstream ProNox Nitrous Oxide Delivery System labeled as the following:
a. CMI-0100 PNX, Pro-Nox Mixer - Canadian;

b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System;

c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator;

d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger;

e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital);

f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger;

g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
Code Information Item Number CMI-0100-PNX-xxx
Recalling Firm/
Manufacturer		 CAREstream Medical LLC
774 Northlake Blvd Ste 1016
Altamonte Springs FL 32701-6709
For Additional Information Contact
407-466-6639
Manufacturer Reason
for Recall		 Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
FDA Determined
Cause 2		 Under Investigation by firm
Action CAREstream Medical Ltd. notified its customers on or about 05/15/2015 via a Medical Device Product Correction letter. The letter informed customers to return their units, (model number: CMI-0100-PNX-xxx) for inspection and upgrade at the firms service center in Florida. So as to allow the customer's continued use of the devices safely during this process (and until all units are upgraded), CAREsteam recommends the device only be used with an oxygen monitor with alarms, attached to the device in accordance with our product manual (refer to Users Manual (revision 6) for instructions). Customers were also instructed to fax or email CAREstream Medical Ltd. to acknowledge receipt of the Medical Device Product Correction letter.
Quantity in Commerce 919 Units Total
Distribution Domestic Distribution: AK, AL, AR ,AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. International Distribution: Canada and Morocco.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BZR and Original Applicant = O-TWO MEDICAL TECHNOLOGIES, INC.
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