Recall Z-2330-2012— Custom Medical Specialties, Inc.
Class II · Terminated
Class II FDA medical device recall by Custom Medical Specialties, Inc., initiated 2011-09-30, terminated 2012-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep. Reason: 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..
- Recalling firm
- Custom Medical Specialties, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-09-30
- Terminated
- 2012-09-10
- Firm location
- Pine Level, NC, United States
Product description
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.