Recall Z-1360-2022— Isopure Corp

Name: FDA recall Z-1360-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-28

Class II · Ongoing

Class II FDA medical device recall by Isopure Corp, initiated 2022-04-28. It names one FDA 510(k) clearance: K112427. Product: Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO). Reason: Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring..

Recalling firm: Isopure Corp
Classification: Class II
Status: Ongoing
Initiated: 2022-04-28
Firm location: Louisville, KY, United States

510(k) clearances named in this recall

1 on FDA's record

K112427 — BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp.·cleared 2012-01-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

Reason for recall

Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring.

Data sourced from openFDA. This site is unofficial and independent of the FDA.