FDA recall Z-1118-2019

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

Distribution

FL, NC

Key facts

Status

Terminated

Initiation date

2019-01-10

Report date

2019-04-17

Termination date

2020-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2019