Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling
FDA device recall Z-1076-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 1008 syringes
- Distribution
- TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
- Date initiated
- 2005-06-27
- Date posted
- 2005-08-03
- Date terminated
- 2007-04-19
- Location
- Athens, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCE DISPOSABLE CONTROL SYRINGE (K911732) | Advance Medical Designs, Inc. | 1991-09-16 |