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Hackensack Meridian Health

Asp Global, LLC · Model HKGNA451L2 · UDI-DI 00840216125889

LYU
10
510(k) clearances
128
Adverse events
9
Recalls
802
Facilities

Description

GOWN, HACKENSACK ISOLATION AAMI LV2, XLARGE, HANDS LOGO, OVER THE HEAD, THUMBLOOP W/ELASTIC WRIST, 10EA/BG, 10BG/CS (100EA/CS)

Recalls

DateFirmReason
2023-05-18MEDLINE INDUSTRIES, LP - NorthfieldProbe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2023-05-15MEDLINE INDUSTRIES, LP - NorthfieldPotential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2017-09-11Zimmer Biomet, Inc.Cut resistant surgical glove liners lack sterility assurance.

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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.