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Recall Observatory FDA recall evidence

Device product

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

Z-0351-2023

October 27, 2022

Class I

Product summary

Firm
ARROW INTERNATIONAL Inc.
Event
Event 91090
Status
Terminated
Classification
Class I
Quantity
80 units
Official record key
device-enforcement:Z-0351-2023

Official wording

Reason: 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.

Code information: UDI/DI 10801902159448, Lot Number 13F22C0349

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.