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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description 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.
Recall Number D-1650-2012
Classification Class II
Code Info Lot #: 25915-1111, Exp 12/2012
Product Distributed Qty 20 Trays
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.

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