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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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.
Recall Number Z-1946-2012
Classification Class II
Code Info Lot Number 204889, Expiration Date March 2017
Product Distributed Qty 10 pieces
Reason For Recall Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.

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 Letter
Distribution Pattern Distributed only in Missouri.