FDAFDA · Food and drugs·Recall number Z-1946-2012
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.
Published July 18, 2012 · Recall initiated: May 4, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Argon Medical Devices, Inc
- Distributor
- Distributed only in Missouri.
- Lot
- Lot Number 204889, Expiration Date March 2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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