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

Recall Z-1267-2017 — Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A

U.S. FDA — Device Enforcement · United States · 2017-01-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1267-2017
Date of alert
2017-01-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Windstone Medical Packaging, Inc.
Product category
device
Product type
Devices
Reported risk: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
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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