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

Recall Z-1305-2017 — General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694

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-1305-2017
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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