Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2328-2012 · Posted 2012-09-07

Recalling FirmCustom Medical Specialties, Inc.
Recall StatusTerminated
Product CodeLRP
Date Initiated2011-09-30
Date Terminated2012-09-10
Product Quantity3 cases

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑