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

Recall Z-1284-2017 — Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part nu

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-1284-2017
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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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