Recalls / —
—#109201
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.
- FDA product code
- DSK — Computer, Blood-Pressure
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K885235
- Affected lot / code info
- Lot Number 204889, Expiration Date March 2017
Why it was recalled
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Root cause (FDA determination)
Packaging
Action the firm took
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 CRS@argonmedical.com for questions regarding this recall.
Recalling firm
- Firm
- Argon Medical Devices, Inc
- Address
- 1445 Flat Creek Rd, Athens, Texas 75751-5002
Distribution
- Distribution pattern
- Distributed only in Missouri.
Timeline
- Recall initiated
- 2012-05-04
- Posted by FDA
- 2012-07-06
- Terminated
- 2013-01-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #109201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.