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Medegen Medical Products, LLC

MEDEGEN MEDICAL PRODUCTS, LLC · Model X1206 · UDI-DI 00673844004635

NNI
0
510(k) clearances
28
Adverse events
4
Recalls
328
Facilities

Description

Bag: Ac 38X47 1.8Ml Red Pr Ind 100/Cs

Recalls

DateFirmReason
2026-03-09Milestone S.R.L.There is a possibility of reagent leakage from the specimen container.
2021-12-01MEDLINE INDUSTRIES, LP - NorthfieldProduct stored incorrectly in temperature controlled setting instead of refrigeration.
2016-03-03Dynarex CorporationExterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
2011-02-18Cardinal Health IncIn one lot of product (lot# 1091745), the label for the small version of the sock (catalog number 65652-123) was improperly used for the larger version of the product (65652-124)

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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.