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

BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep — recall Z-2360-2012

U.S. FDA — Device Enforcement · United States · 2011-09-30 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2360-2012
Date of alert
2011-09-30
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Custom Medical Specialties, Inc.
Product category
device
Product type
Devices
Reported risk: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
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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