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ProGen Phlebotomy Kit

CELLMEDIX HOLDINGS, LLC · Model BELL-82500-A · UDI-DI 00861122000336

OFM
0
510(k) clearances
0
Adverse events
2
Recalls
17
Facilities

Recalls

DateFirmReason
2021-04-09Medical Action Industries, Inc. 306Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
2010-12-06Continental Medical Labs,IncContinental Medical labs, Inc, is recalling various lots of Blood Center Kit and Port VAD Kits because Covidien reported that testing could not pick up an Over-Sulfated Chondro

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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.