Home / Recalls / Custom Medical Specialties, Inc. / Z-2329-2012

Z-2329-2012 Class II Terminated

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

FDA device recall Z-2329-2012 was initiated by Custom Medical Specialties, Inc. on September 30, 2011 and is designated Class II. 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. The recall status is terminated (terminated September 10, 2012). Affected quantity: 16 cases.

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
16 cases

Product Description

CMS-2890 Custom Needle Local Tray containing PVP Prep Pad 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

16480-0908, 20976-1008, 21283-1009

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