CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used

FDA device recall Z-2349-2012 · posted 2012-09-20 · Terminated

Recall details

Recalling firm

Custom Medical Specialties, Inc.

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.

Action taken

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

Status

Terminated

Product code

LRO

Quantity affected

5 cases

Distribution

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

Date initiated

2011-09-30

Date posted

2012-09-20

Date terminated

2013-04-29

Location

Pine Level, NC