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FDA (Device enforcement)Recalled 2022-05-05closedclass ii

ARROW INTERNATIONAL Inc.: Arrow Three-Lumen CVC

Is my product affected?

Arrow Three-Lumen CVC

  • UPC 20801902122838
  • UPC 10801902136944
  • UPC 10801902179514
  • UPC 10801902170856

Check against the official notice below — it lists the full affected range.

What happened

Arrow International Inc. has recalled 10,301 units of Arrow Three-Lumen CVC central venous catheters due to incorrect gravity flow rates on the product lidstock. The affected product, catalog number CV-12123-F, was distributed nationwide in Florida across 23 specific lot numbers manufactured between December 2021 and February 2026.

The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Gravity flow rates on the affected product lidstock are incorrect.

Details from the source

Reason for recall: Gravity flow rates on the affected product lidstock are incorrect. Distribution: US Nationwide distribution in the states of Florida. Quantity: 10,301 units Lot/code info: Catalog Number: CV-12123-F; Lot Numbers: 71F20A0430 [UDI: (01)20801902122838(17)211214(10)71F20A0430], 71F20A2583 [UDI: (01)20801902122838(17)250103(10)71F20A2583], 71F20B0793 [UDI: (01)20801902122838(17)250115(10)71F20B0793], 71F20B2188 [UDI: (01)20801902122838(17)250204(10)71F20B2188], 71F20C1356 [UDI: (01)10801902136944(17)220630(10)71F20C1356], 71F20D1047 [UDI: (01)20801902122838(17)250402(10)71F20D1047], 71F20E2225 [UDI: (01)20801902122838(17)250531(10)71F20E2225], 71F20G2376 [UDI: (01)20801902122838(17)250701(10)71F20G2376], 71F20K0771 [UDI: (01)20801902122838(17)241130(10)71F20K0771], 71F20K2265 [UDI: (01)20801902122838(17)250228(10)71F20K2265], 71F20L0567 [UDI: (01)20801902122838(17)250228(10)71F20L0567], 71F20M1262 [UDI: (01)20801902122838(17)250331(10)71F20M1262], 71F21B0849 [UDI: (01)10801902179514(17)250430(10)71F21B0849], 71F21B0850 [UDI: (01)20801902122838(17)250430(10)71F21B0850], 71F21B2430 [UDI: (01)20801902122838(17)250430(10)71F21B2430], 71F21C0637 [UDI: (01)20801902122838(17)250331(10)71F21C0637], 71F21C0964 [UDI: (01)10801902170856(17)260214(10)71F21C0964], 71F21D0025 [UDI: (01)20801902122838(17)250430(10)71F21D0025], 71F21E0586 [UDI: (01)20801902122838(17)250430(10)71F21E0586], 71F21E1030 [UDI: (01)20801902122838(17)250430(10)71F21E1030], 71F21E2583 [UDI: (01)20801902122838(17)250430(10)71F21E2583], 71F21F1156 [UDI: (01)20801902122838(17)250430(10)71F21F1156], 71F21J0698 [UDI: (01)20801902122838(17)250430(10)71F21J0698]

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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