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

Recall Z-0270-2017 — Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room

U.S. FDA — Device Enforcement · United States · 2015-04-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0270-2017
Date of alert
2015-04-22
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, Part # 13140, of the custom AMS kit 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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