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VYGON

Vygon Corporation · Model AMS-6186CP · UDI-DI 00849884002829

OWL
0
510(k) clearances
82
Adverse events
16
Recalls
36
Facilities

Description

PREP KIT

Recalls

DateFirmReason
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-03-11ARROW INTERNATIONAL, LLCDue to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
2025-12-22LSL Healthcare Inc.BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
2022-12-15Stradis HealthcarePotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
2022-12-15Stradis HealthcarePotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
2022-12-15Stradis HealthcarePotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
2022-10-12Medical Action Industries, Inc. 306The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
2020-06-15Access Scientific LLCConvenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user d
2018-02-28Vygon U.S.A.Potential friction holes may affect the sterility of the product.
2018-02-28Vygon U.S.A.Potential friction holes may affect the sterility of the product.

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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.