Class II Recall

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not

Summary

The FDA issued a Class II for Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with by ARROW INTERNATIONAL Inc.. Reason: Reports have been received regarding open seals on the packaging..

Details

Source

Device Recall

External ID

Z-3299-2024

Action Date

2024-10-02

Status

Ongoing

Product Description

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

Lot/Code Info: (1) REF ASK-04001-BW1: Batch numbers 33F23M0157, 33F24C0002, 33F24C0136, and 33F23L0297, UDI-DI: 10801902117585; (2) REF ASK-04001-CK: Batch numbers 33F24A0390, 33F24B0233, 33F24A0260, 33F24A0036, and 33F23L0738, UDI-DI: 00801902091215; (3) REF ASK-04001-VAMC1: Batch numbers 33F24A0825 and 33F24B0235, UDI-DI: 10801902158854; (4) REF ASK-04020-BHS: Batch numbers 33F24C0678, 33F23K0881, 33F24B0788, 33F24A1676, 33F24A0711, and 33F23L0687, UDI-DI: 30801902144578; (5) REF ASK-04020-BID: Batch number 33F23J0777, UDI (1)10801902211429(17)260331(10)33F23J0777; (6) REF ASK-04020-HMC: Batch numbers 33F24A0743, 33F23L0747, and 33F24A1129, UDI-DI: 10801902117691; (7) REF ASK-04020-HOA: Batch number 33F24D0969, UDI: (1)10801902214802(17)251124(10)33F24D0969; (8) REF ASK-04020-KSD: Batch number 33F24D0964, UDI: (1)10801902219630(17)251130(10)33F24D0964; (9) REF ASK-04020-LOL: Batch numbers 33F24A1135, 33F24B0254, 33F24A0731, 33F24A0314, and 33F23M0033, UDI-DI 10801902144765; (10) REF ASK-04020-MHS: Batch numbers 33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, and 33F23L0734, UDI-DI 20801902117711(17)260426; (11) REF ASK-04020-MIB3: Batch number 33F24A0901, UDI (1)10801902206401(17)250831(10)33F24A0901; (12) REF ASK-04020-PRH: Batch number 33F23K0602, UDI (1)10801902155938(17)250731(10)33F23K0602; (13) REF ASK-04020-UOIL: Batch number 33F24B0001, UDI (1)10801902218978(17)261031(10)33F24B0001; (14) REF ASK-04220-KSP: Batch number 33F23L0323, UDI (1)10801902156409(17)250531(10)33F23L0323; and (15) REF ASK-04500-HFH4: Batch numbers 33F24C0436, 33F24A0617, and 33F23K1006, UDI-DI 10801902200461.

Quantity Affected: 14,845 kits

Reason for Recall

Reports have been received regarding open seals on the packaging.

Distribution

US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-07-26

Company

ARROW INTERNATIONAL Inc.

Morrisville, NC

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.

ARROW INTERNATIONAL Inc. has 55 FDA actions in our database, including 55 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARROW INTERNATIONAL Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does ARROW INTERNATIONAL Inc. have FDA actions?

ARROW INTERNATIONAL Inc. has 55 FDA actions in our database, including 55 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-3299-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29