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ADDaSEAL RE Adhesive Face Mask Strips

PRACTICON, INC. · Model 7154411 · UDI-DI 00723896018897

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

Description

Adhesive strip to be placed on the bridge of any face mask to create an airtight seal. Adhesive is repositionable on the skin side, making it better for sensitive skin and longer procedures.

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.