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

FDA device recall Z-2330-2012 · posted 2012-09-07 · 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 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 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

Status

Terminated

Product code

LRP

Quantity affected

4 cases

Distribution

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

Date initiated

2011-09-30

Date posted

2012-09-07

Date terminated

2012-09-10

Location

Pine Level, NC