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

Recall Z-1505-2013 — FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.

U.S. FDA — Device Enforcement · United States · 2013-04-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1505-2013
Date of alert
2013-04-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
American Optisurgical Inc
Product category
device
Product type
Devices
Reported risk: American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.
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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