Recall Z-1115-2019— Vygon U.S.A.
Class II · Terminated
Class II FDA medical device recall by Vygon U.S.A., initiated 2018-12-06, terminated 2020-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.. Reason: DualStop Caps defect causing leaks in affected product.
- Recalling firm
- Vygon U.S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-06
- Terminated
- 2020-05-12
- Firm location
- Lansdale, PA, United States
Product description
Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
Reason for recall
DualStop Caps defect causing leaks in affected product
Data sourced from openFDA. This site is unofficial and independent of the FDA.