Data Foundry

Medical device recalls 2022

Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 — Class I medical device recall Z-0351-2023

Terminated recall by ARROW INTERNATIONAL Inc., reported 2022-12-21, distributed in FL, GA, KY, OH, PA, WV. There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear

Recall numberZ-0351-2023
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmARROW INTERNATIONAL Inc., Morrisville, NC, United States
Recall initiated2022-10-27
Classified2022-12-09
Reported by FDA2022-12-21
Terminated2024-10-07
DistributedFL, GA, KY, OH, PA, WV
Quantity80 units
UPC / GTIN / UDI-DI10801902159448
Lot numbers13F22C0349
Model numbersASK-11242-UPM1

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0351-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.