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 | Letter |
| 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 |
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