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Alleset

GRI Medical & Electronic Technology Co., Ltd. · Model 60-3078 · UDI-DI 16931918151083

FYC
10
510(k) clearances
28
Adverse events
2
Recalls
56
Facilities

Description

AMMI3 Isolation gown_Large_40g SMS_Non-sterile_100ea/cs

Recalls

DateFirmReason
2024-11-01Cardinal Health 200, LLCIsolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancem
2024-11-01Cardinal Health 200, LLCIsolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancem

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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.