FDA Enforcement
Class II
Terminated
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.
Recall: Z-1946-2012
·
Reported July 18, 2012
Enforcement
- Recall Number
- Z-1946-2012
- Event ID
- 61832
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Argon Medical Devices, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 18, 2012
- Initiation Date
- May 4, 2012
- Classification Date
- July 6, 2012
- Termination Date
- January 14, 2013
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002, United States
Description
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
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Code Info
Lot Number 204889, Expiration Date March 2017
Distribution
Distributed only in Missouri.
Quantity
10 pieces