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Argon Medical Devices, Inc recalls Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical
Recalled July 18, 2012 · FDA recall Z-1946-2012 · Argon Medical Devices
Hazard
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier. · FDA Class II
Units
10 pieces
Sold at
Distributed only in Missouri.
Description
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Product
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.
Manufacturer(s)
Argon Medical Devices, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →