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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 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.
Recall Number D-1649-2012
Classification Class II
Code Info Lot #: 25744-1111, Exp 09/2012
Product Distributed Qty 35 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