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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 61832
Product Type Devices
Status Ongoing
Recalling Firm Argon Medical Devices, Inc
City Athens
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-04
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed only in Missouri.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment. Lot Number 204889, Expiration Date March 2017 Class II Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier. 10 pieces Z-1946-2012