Z-1118-2019 Class II Terminated
FDA device recall Z-1118-2019 was initiated by Arrow International Inc on January 10, 2019 and is designated Class II. 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 The recall status is terminated (terminated June 4, 2020). Affected quantity: None (US).
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2019
- Initiation Date
- January 10, 2019
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- None (US)
Product Description
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
Distribution Pattern
FL, NC
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