Recalls / —

—#193573

Product

Arrow Three-Lumen CVC

FDA product code

FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K970864

Affected 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]

Why it was recalled

Gravity flow rates on the affected product lidstock are incorrect.

Root cause (FDA determination)

Error in labeling

Action the firm took

A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form. An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope remains the same.

Recalling firm

Firm

ARROW INTERNATIONAL Inc.

Address

3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern

US Nationwide distribution in the states of Florida.

Timeline

Recall initiated

2022-05-05

Posted by FDA

2022-06-27

Terminated

2024-09-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #193573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.