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Terminated

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

FDA Recall Z-2349-2012 · Posted 2012-09-20

Recalling FirmCustom Medical Specialties, Inc.
Recall StatusTerminated
Product CodeLRO
Date Initiated2011-09-30
Date Terminated2013-04-29
Product Quantity5 cases

Reason for Recall

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.

Firm Action

Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.

Root Cause

Material/Component Contamination

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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