Home / Recalls / Custom Medical Specialties, Inc. / Z-2349-2012

Z-2349-2012 Class I Terminated

Recalled by Custom Medical Specialties, Inc. — Pine Level, NC

Recall Details

Product Type
Devices
Report Date
September 26, 2012
Initiation Date
September 30, 2011
Termination Date
April 29, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 cases

Product Description

CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle 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 in place at the manufacturer and product did not meet proper finished goods specifications.

Distribution Pattern

US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.

Code Information

20182-1006

Other recalls by Custom Medical Specialties, Inc.

  • Z-1234-2017 Class II — CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, (September 20, 2016)
  • Z-0974-2014 Class II — 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Spec (July 12, 2013)
  • D-1649-2012 Class II — Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CM (July 23, 2012)
  • D-1651-2012 Class II — CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride (July 23, 2012)
  • D-1650-2012 Class II — CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, (July 23, 2012)
  • Z-2356-2012 Class I — CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Produc (September 30, 2011)
  • Z-2352-2012 Class I — CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Produc (September 30, 2011)
  • Z-2360-2012 Class I — BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep S (September 30, 2011)
  • Z-2350-2012 Class I — CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Pr (September 30, 2011)
  • Z-2329-2012 Class II — CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in (September 30, 2011)