FDA-Device2012-07-18Class II
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.
Argon Medical Devices, Inc
Hazard
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Sold states
Distributed only in Missouri.
Affected count
10 pieces
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2012Don't want to check this manually?
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