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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012
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Event Detail

Event ID 62775
Product Type Drugs
Status Ongoing
Recalling Firm Custom Medical Specialties, Inc.
City Pine Level
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-23
Initial Firm Notification of
Consignee or Public		 FAX
Distribution Pattern GA, MD, MA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #: 25744-1111, Exp 09/2012 Class II 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 35 Trays D-1649-2012
CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description. Lot #: 25915-1111, Exp 12/2012 Class II 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. 20 Trays D-1650-2012
CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description. Lot #: 26124-1112, Exp 12/2012 Class II 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. 25 Trays D-1651-2012
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