Recall Z-1345-2016— AngioDynamics Inc.
Class II · Terminated
Class II FDA medical device recall by AngioDynamics Inc., initiated 2015-11-03, terminated 2017-03-16. FDA's recall record names no specific 510(k) clearance for this event. Product: NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire. Reason: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036"..
- Recalling firm
- AngioDynamics Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-03
- Terminated
- 2017-03-16
- Firm location
- Glens Falls, NY, United States
Product description
NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
Reason for recall
Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".
Data sourced from openFDA. This site is unofficial and independent of the FDA.