The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
Reason for recall: The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits. Distribution: Distribution was made to MN. There was no foreign/government/military distribution. Quantity: 24 cases (480 kits) Lot/code info: Port Access Kit case label - Lot 294281, exp. 9/28/2023, UDI #1080916018095. IV Start Kit label - Lot 294589, exp. 12/20/2024, UDI #20809160195991.
1080916018095, 20809160195991
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.