Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0933-2018 — Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

U.S. FDA — Device Enforcement · United States · 2017-10-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0933-2018
Date of alert
2017-10-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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