Custom Medical Specialties, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2350-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 30, 2011

Date Posted: September 26, 2012

Recall Number: Z-2350-2012

Event ID: 62132

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 and product did not meet proper finished goods specifications.

Status: Terminated

Product Quantity: 3 cases

Code Information:

15011-0904 and 16363-0908

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated