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

Recall Z-2349-2012 — CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep

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-2349-2012
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 in place at the manufacturer and product did not meet proper finished goods specifications.
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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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.