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.
FDA Recall Z-1946-2012 · Posted 2012-07-06
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Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDSK
Date Initiated2012-05-04
Date Terminated2013-01-14
Product Quantity10 pieces
Reason for Recall
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Firm Action
Argon Medical Devices sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Recall Response Form was attached to the letter for customers to complete and return to the firm via fax to 903-577-9393. Contact the firm at [email protected] for questions regarding this recall.
Root Cause
Packaging
Distribution Pattern
Distributed only in Missouri.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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