Recall Z-1329-2021— Oscor, Inc.
Class II · Terminated
Class II FDA medical device recall by Oscor, Inc., initiated 2021-03-10, terminated 2023-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.. Reason: Potential for open seal on sterile product.
- Recalling firm
- Oscor, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-10
- Terminated
- 2023-08-08
- Firm location
- Palm Harbor, FL, United States
Product description
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Reason for recall
Potential for open seal on sterile product
Data sourced from openFDA. This site is unofficial and independent of the FDA.