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JMU

JMU DENTAL, INC · Model 25407011 · UDI-DI 00840456216569

LYU
10
510(k) clearances
128
Adverse events
9
Recalls
800
Facilities

Description

JMU Disposable Isolation Gown, 30 gsm PP, Knitted Cuffs, Green, 120 × 140 cm. Packaged as 100 pcs per case. Sold by case.

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.