Class II — Argon Medical Devices, Inc
| Recalling firm | ARGON MEDICAL DEVICES, INC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 10 pieces |
| Distribution | Distributed only in Missouri. |
| Initiated | 2012-05-04 |
| Classified | 2012-07-06 |
| Terminated | 2013-01-14 |
| Recall number | Z-1946-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Argon Medical Devices, Inc (Z-1946-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61832/
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