Custom Medical Specialties, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2330-2012)

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

Product Classification:

Class II

Date Initiated: September 30, 2011

Date Posted: September 19, 2012

Recall Number: Z-2330-2012

Event ID: 62875

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4 cases

Code Information:

20179-1006

Distribution Pattern:

Nationwide Distribution including GA, MI, NY, and PA.

Voluntary or Mandated:

Voluntary: Firm initiated