Data Foundry

Medical device recalls 2019

Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue… — Class II medical device recall Z-1118-2019

Terminated recall by Arrow International Inc, reported 2019-04-17, distributed in FL, NC. The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming

Recall numberZ-1118-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArrow International Inc, Reading, PA, United States
Recall initiated2019-01-10
Classified2019-04-10
Reported by FDA2019-04-17
Terminated2020-06-04
DistributedFL, NC
UPC / GTIN / UDI-DI00801902026132
Lot numbers71F14E0696, 71F14E1541, 71F14F1154, 71F14H0474, 71F14H1215, 71F14J0852, 71F14J1889, 71F14K0658, 71F14K1683, 71F14L0719, 71F14M1375, 71F15A0025, 71F15A1592, 71F15D1460, 71F15E0493, 71F15F0090, 71F15H0574, 71F15H1503, 71F15J0570, 71F15J2098, 71F15L0153, 71F15L0621, 71F15M0787, 71F16A0278, 71F16B0054, 71F16B1306

Product

Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

Reason for recall

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

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-1118-2019. 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.