Recall Z-2180-2012— Angiodynamics Worldwide Headquarters
Class II · Terminated
Class II FDA medical device recall by Angiodynamics Worldwide Headquarters, initiated 2012-06-15, terminated 2016-02-10. It names one FDA 510(k) clearance: K061733. Product: AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.. Reason: AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled..
- Recalling firm
- Angiodynamics Worldwide Headquarters
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-15
- Terminated
- 2016-02-10
- Firm location
- Latham, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.
Reason for recall
AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.