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Recall Observatory FDA recall evidence

Device product

CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep

Z-2350-2012

September 30, 2011

Class I

Product summary

Firm
Custom Medical Specialties, Inc.
Event
Event 62132
Status
Terminated
Classification
Class I
Quantity
3 cases
Official record key
device-enforcement:Z-2350-2012

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 and product did not meet proper finished goods specifications.

Code information: 15011-0904 and 16363-0908

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 and product did not meet proper finished goods specifications.