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Recall Observatory FDA recall evidence

Device product

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

Z-2349-2012

September 30, 2011

Class I

Product summary

Firm
Custom Medical Specialties, Inc.
Event
Event 62132
Status
Terminated
Classification
Class I
Quantity
5 cases
Official record key
device-enforcement:Z-2349-2012

Official wording

Reason: 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.

Code information: 20182-1006

Distribution pattern: US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.