Z-0351-2023 Class I Terminated
FDA device recall Z-0351-2023 was initiated by ARROW INTERNATIONAL Inc. on Oct 27, 2022 and is designated Class I. 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… The recall status is terminated (terminated Oct 7, 2024). Affected quantity: 80 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Oct 27, 2022
- Termination Date
- Oct 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units
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.
Distribution Pattern
US Distributor in states of: FL, GA, KY, OH, PA and WV.
Code Information
UDI/DI 10801902159448, Lot Number 13F22C0349
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0351-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026