Home / Recalls / Custom Medical Specialties, Inc. / Z-2328-2012

Z-2328-2012 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
September 19, 2012
Initiation Date
September 30, 2011
Termination Date
September 10, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 cases

Product Description

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

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.

Distribution Pattern

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

Code Information

19207-1004

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-2358-2012 Class I — CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Us (September 30, 2011)
  • Z-2354-2012 Class I — CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution (September 30, 2011)
  • Z-2357-2012 Class I — CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 o (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)