Z-2349-2012Class I

CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle

Name: Z-2349-2012 CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle
Creator: Custom Medical Specialties, Inc.
Published: 2011-09-30
License: https://open.fda.gov/license/

Custom Medical Specialties, Inc. / initiated 2011-09-30 / Terminated / root cause: manufacturing process

FDA source

Custom Medical Specialties, Inc. began a recall of 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 on 2011-09-30. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2349-2012
Classification: Class I
Status: Terminated
Initiated: 2011-09-30
Posted: 2012-09-20
Terminated: 2013-04-29
Recalling firm: Custom Medical Specialties, Inc.
Product: 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
Product code: LRO General Surgery Tray
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
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.
Quantity in commerce: 5 cases
Distribution: US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Product codes and lots: 20182-1006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2349-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2349-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2350-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2351-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2352-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2353-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2354-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2355-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2356-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2357-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2358-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2359-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2360-2012	Class I	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)