Device 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.
Z-1946-2012
Product summary
- Event
- Event 61832
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 pieces
- Official record key
device-enforcement:Z-1946-2012
Official wording
Reason: Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Code information: Lot Number 204889, Expiration Date March 2017
Distribution pattern: Distributed only in Missouri.
Derived failure modes
-
Labeling or packaging
pouch seal. The pouch issue may compromise
-
Sterility assurance
seal. The pouch issue may compromise the sterile