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LCG2b with AS-1, AS-3 and AS-5
MACO PHARMA · Model KSV · UDI-DI 03567050035347
CAK
Prescription
10
510(k) clearances
1,660
Adverse events (7 deaths)
1
Recalls
14
Facilities
Description
Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GVS TM, Inc | Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. |
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Get your free API keyRead the docsData 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.