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SURGIPLUS

KENPAX INTERNATIONAL LIMITED · Model 1 · UDI-DI 74895237141528

LYU

510(k) clearances

128

Adverse events

Recalls

800

Facilities

Description

Warm-up Jacket, Blue, L A non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

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.