Home / Recalls / Custom Medical Specialties, Inc. / D-1649-2012

D-1649-2012 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
August 29, 2012
Initiation Date
July 23, 2012
Termination Date
October 11, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35 Trays

Product Description

Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.

Reason for Recall

Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags

Distribution Pattern

GA, MD, MA

Code Information

Lot #: 25744-1111, Exp 09/2012

Other recalls by Custom Medical Specialties, Inc.

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  • 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-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)
  • Z-2356-2012 Class I — CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Produc (September 30, 2011)