Recall Z-2556-2019— Arrow International Inc

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2019-08-06, terminated 2020-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.. Reason: Products may contain the incorrect banner card within the kit.

Recalling firm
Arrow International Inc
Classification
Class II
Status
Terminated
Initiated
2019-08-06
Terminated
2020-09-29
Firm location
Reading, PA, United States

Product description

Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.

Reason for recall

Products may contain the incorrect banner card within the kit

Data sourced from openFDA. This site is unofficial and independent of the FDA.