Recall Z-2887-2018 ยท BZR Mixer, Breathing Gases, Anesthesia Inhalation
CAREstream Medical LLC
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
| Date | May 15, 2018 |
| Status | Terminated |
| Reason | Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing. |
| Root cause | 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). Custom |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113687 | EQUINOX RELIEVE O-Two Medical Technologies, Inc., Apr 30, 2012 |