Recall Z-1077-05 ยท IZI System, X-Ray, Angiographic
Argon Medical Devices, Inc
Labeling is as follows: Product Labeling: ''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy 1-Way w/ MLL***1 72'' Vented Spike Line***1 10cc Control Syringe***1 M/F L/L PVC Line*** 1 Stopcock Assy 4-way w/ MLL***1 Rotating Adapter, M/M***1 35/150/FC/PTFE/3J/XTB Guidewire***1 Angio Flushing S
| Date | Aug 3, 2005 (initiated Jun 27, 2005) |
| Status | Terminated |
| Reason | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. |
| Root cause | Other |
| Action | The firm plans to distribute recall letters to all customers indicated on the customer list. TELEPHONE 6/27/2005. All products will be returned to Argon and disposed. |
| Quantity | 160 kits |
| Distribution | TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE Advance Medical Designs, Inc., Sep 16, 1991 |