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MCB Series

MAR COR PURIFICATION, INC. · Model MCB 212-50 BICARB SEMI SYS · UDI-DI 00817492020993

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510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2022-04-28	Isopure Corp	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 compone
2019-04-19	Isopure Corp	There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use
2012-03-26	Tango3 LLC	During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either n
2006-11-12	Hill-Rom, Inc.	False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handl

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.