FDAClass IDecember 21, 2022

Arrow MAC Two-Lumen Central Venous Access Kit fr use recall

Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

Why was Arrow MAC Two-Lumen Central Venous Access Kit fr use recalled?

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 10801902159448, Lot Number 13F22C0349

Product
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Recalling firm
ARROW INTERNATIONAL Inc.
Quantity
80 units
Distribution
US Distributor in states of: FL, GA, KY, OH, PA and WV.
Recall date
December 21, 2022
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls