Z-2328-2012Class II

CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is...

Name: Z-2328-2012 CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is...
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-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep on 2011-09-30. FDA classified it as Class II and gives the reason as "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". 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-2328-2012
Classification: Class II
Status: Terminated
Initiated: 2011-09-30
Posted: 2012-09-07
Terminated: 2012-09-10
Recalling firm: Custom Medical Specialties, Inc.
Product: CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Product code: LRP Tray, Surgical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Custom Medical Specialties sent an Urgent Medical Device Recall letter dated August 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory for the affected product and to discontinue the use of any affected product. Customer were instructedto complete and return the Return Response form, acknowledging they have received the letter and checked their inventory. Any product still in the customers inventory should be returned to the firm. Customers should call (919) 202-8462, ext 205 to obtain a Return Authorization Number and the shipping number. For questions regarding this recall call 919-202-8462.
Quantity in commerce: 3 cases
Distribution: Nationwide Distribution including GA, MI, NY, and PA.
Product codes and lots: 19207-1004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2328-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2328-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07
Z-2329-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07
Z-2330-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07
Z-2331-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07

Product code LRP

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)