FDA Device recall Z-1118-2019
Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
- FDA Device
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132 by Arrow International, citing the product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1118-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-10 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Arrow International |
| Distribution | FL, NC |
Product
Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Reason
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Identifiers
| code_info | Lot Numbers: 71F14E0696 71F14K0658 71F15E0493 71F15L0621 71F14E1541 71F14K1683 71F15F0090 71F15M0787 71F14F1154 71F…Lot Numbers: 71F14E0696 71F14K0658 71F15E0493 71F15L0621 71F14E1541 71F14K1683 71F15F0090 71F15M0787 71F14F1154 71F14L0719 71F15H0574 71F16A0278 71F14H0474 71F14M1375 71F15H1503 71F16B0054 71F14H1215 71F15A0025 71F15J0570 71F16B1306 71F14J0852 71F15A1592 71F15J2098 71F14J1889 71F15D1460 71F15L0153 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.