Safedraw Venous Close Loop System — Class II medical device recall Z-1946-2012
Terminated recall by Argon Medical Devices, Inc, reported 2012-07-18, distributed in MO. Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the steril
| Recall number | Z-1946-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2012-05-04 |
| Classified | 2012-07-06 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-01-14 |
| Distributed | MO |
| Quantity | 10 units |
| Reason classes | sterility, packaging |
| Lot numbers | 204889 |
| Model numbers | 688695 |
| Expiration dates | 2017-03-20 |
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.
Reason for recall
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1946-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.