Recall Z-1635-2018— Vygon U.S.A.
Class II · Terminated
Class II FDA medical device recall by Vygon U.S.A., initiated 2018-02-28, terminated 2019-02-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.. Reason: Potential friction holes may affect the sterility of the product..
- Recalling firm
- Vygon U.S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-28
- Terminated
- 2019-02-19
- Firm location
- Lansdale, PA, United States
Product description
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Reason for recall
Potential friction holes may affect the sterility of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.