Home / Recalls / Custom Medical Specialties, Inc. / Z-2351-2012

Z-2351-2012 Class I Terminated

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

FDA device recall Z-2351-2012 was initiated by Custom Medical Specialties, Inc. on September 30, 2011 and is designated Class I. 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. The recall status is terminated (terminated April 29, 2013). Affected quantity: 6 cases.

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
6 cases

Product Description

CMS-4316 Custom Vein 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.

Distribution Pattern

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

Code Information

15287-0905, 15974-0906, 17052-0910

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-1651-2012 Class II — CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride (July 23, 2012)
  • D-1649-2012 Class II — Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CM (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-2353-2012 Class I — CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product (September 30, 2011)
  • 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-2356-2012 Class I — CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Produc (September 30, 2011)

FDA data resources