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

Recall Z-2330-2012 — CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep

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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2330-2012
Date of alert
2011-09-30
Country / jurisdiction
United States
Risk level
Class II
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 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.