Recall archive / FDA device enforcement
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer — FDA record Z-0351-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
- 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.
- Classification
- Class I
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 80 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0351-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 10801902159448, Lot Number 13F22C0349 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distributor in states of: FL, GA, KY, OH, PA and WV.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 21, 2022
- Recall initiation date
- Oct 27, 2022
- Center classification date
- Dec 9, 2022
- Termination date
- Oct 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.