Reported Oct 2, 2024 · Ongoing

Arrow Arterial Kits and Trays as follows

ARROW INTERNATIONAL Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ARROW INTERNATIONAL Inc. · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437

Is this the product you have?

Arrow Arterial Kits and Trays as follows

15 of 15 products

Products covered by this recall
Model / numberProduct as published
ASK-04001-BW1(1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included)
ASK-04001-CK(2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included)
ASK-04001-VAMC1(3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide
ASK-04020-BHS(4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide
ASK-04020-BID(5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide
ASK-04020-HMC(6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide
ASK-04020-HOA(7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide
ASK-04020-KSD(8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide
ASK-04020-LOL(9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide
ASK-04020-MHS(10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide
ASK-04020-MIB3(11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide
ASK-04020-PRH(12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide
ASK-04020-UOIL(13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide
ASK-04220-KSP(14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide
ASK-04500-HFH4.and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide
Amount recalled
14,845 kits

Where it was sold

Why it was recalled

Reports have been received regarding open seals on the packaging.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new ARROW INTERNATIONAL Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.