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Clear-All Face Shield

PRACTICON, INC. · Model 701787 · UDI-DI 00723896017678

LYU

510(k) clearances

127

Adverse events

Recalls

803

Facilities

Description

Finally, there is a face shield specifically designed to fit over loupes and headlamps. The Clear-All Face Shield is super lightweight and comfortable with ample forward clearance. Black hook-and-loop headband doubles as forehead pad. Entire shield can be washed and reused. Antifog PET construction. 12" long with extended wraparound protection. Eight complete shields per pack.

Recalls

Date	Firm	Reason
2023-05-18	MEDLINE INDUSTRIES, LP - Northfield	Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2023-05-15	MEDLINE INDUSTRIES, LP - Northfield	Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
2021-01-07	Cardinal Health 200, LLC	Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07	Cardinal Health 200, LLC	Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07	Cardinal Health 200, LLC	Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07	Cardinal Health 200, LLC	Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07	Cardinal Health 200, LLC	Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07	Cardinal Health 200, LLC	Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2017-09-11	Zimmer 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.