Recall Z-2357-2012— Custom Medical Specialties, Inc.
Class I · Terminated
Class I FDA medical device recall by Custom Medical Specialties, Inc., initiated 2011-09-30, terminated 2013-04-29. FDA's recall record names no specific 510(k) clearance for this event. Product: CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep. Reason: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications..
- Recalling firm
- Custom Medical Specialties, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2011-09-30
- Terminated
- 2013-04-29
- Firm location
- Pine Level, NC, United States
Product description
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP 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 of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.