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
- Recall Number
- Z-1946-2012
- Event Number
- 61832
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- DSK
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- May 4, 2012
- Posted
- July 6, 2012
- Terminated
- January 14, 2013
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
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.
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
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.
Distributed only in Missouri.
10 pieces