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

D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room — recall Z-0170-2017

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-0170-2017
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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