Device product

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

Z-1118-2019

January 10, 2019

Class II

Product summary

Firm: Arrow International Inc
Event: Event 82070
Status: Terminated
Classification: Class II
Quantity: None (US)
Official record key: device-enforcement:Z-1118-2019

Official wording

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

Code information: 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

Distribution pattern: FL, NC

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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