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Recall Observatory FDA recall evidence

Device product

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

Z-2330-2012

September 30, 2011

Class II

Product summary

Firm
Custom Medical Specialties, Inc.
Event
Event 62875
Status
Terminated
Classification
Class II
Quantity
4 cases
Official record key
device-enforcement:Z-2330-2012

Official wording

Reason: 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.

Code information: 20179-1006

Distribution pattern: Nationwide Distribution including GA, MI, NY, 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 due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.