Data Foundry

Medical device recalls 2026

MAC" Two-Lumen Central Venous Access Kit for use with 7 — Class II medical device recall Z-1916-2026

Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-04-29, distributed nationwide. Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Recall numberZ-1916-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmARROW INTERNATIONAL, LLC, Morrisville, NC, United States
Recall initiated2026-03-11
Classified2026-04-22
Reported by FDA2026-04-29
DistributedNationwide (US)
Quantity90
UPC / GTIN / UDI-DI10801902206807
Lot numbers33F25M0670
Model numbersASK-11142-LC2

Product

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

Reason for recall

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

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-1916-2026. 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.