Recall Z-1078-05 ยท IZI System, X-Ray, Angiographic
Argon Medical Devices, Inc
Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***REORDER NO./REF 193205***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***STERILE***EO***STERILIZED BY
| 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 | 203 syringes |
| 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 |