Recall Z-1946-2012 ยท DSK Computer, Blood-Pressure
Argon Medical Devices, Inc
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.
| Date | Jul 6, 2012 (initiated May 4, 2012) |
| Status | Terminated |
| Reason | Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier. |
| Root cause | Packaging |
| Action | 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. |
| Quantity | 10 pieces |
| Distribution | Distributed only in Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. Spectramed, Inc., Jan 25, 1989 |