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Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM...

FDA Recall #Z-0351-2023 — Class I — October 27, 2022

Recall #Z-0351-2023 Date: October 27, 2022 Classification: Class I Status: Terminated

Product Description

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

Reason for Recall

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.

Recalling Firm

ARROW INTERNATIONAL Inc. — Morrisville, NC

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

80 units

Distribution

US Distributor in states of: FL, GA, KY, OH, PA and WV.

Code Information

UDI/DI 10801902159448, Lot Number 13F22C0349

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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