ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, ST
FDA device recall Z-1733-2010 · posted 2010-05-28 · Terminated
Recall details
- Recalling firm
- Angiodynamics, Inc.
- Reason for recall
- Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.
- Action taken
- Angiodynamics, Inc. issued an "Urgent Medical Device Recall" notification (dated 4/28/10). Customers were advised of the affected product and instructed to return all recalled product to the firm. For further information, contact Angiodynamics, Inc. Customer Service at 1-800-772-6446.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 741
- Distribution
- Distributed Nationwide and to Italy
- Date initiated
- 2010-04-30
- Date posted
- 2010-05-28
- Date terminated
- 2012-07-25
- Location
- Queensbury, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLOWMEDICA BENEPHIT INFUSION SYSTEMS (K082163) | Flowmedica, Inc. | 2008-10-29 |
| BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH (K050205) | Flowmedica, Inc. | 2005-03-04 |
| FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH (K033569) | Flowmedica, Inc. | 2004-01-13 |