Lower risk Medical device recall · FDA · Published November 14, 2017

Arrow CVC Kit Lacks Safety Checklist: Recall for Central Line Insertion

Arrow recalls Blue PLUS Pressure Injectable Multi-Lumen CVC Kits that lack critical safety checklists for central line insertions. This may lead to errors during medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1166-2018Medical device Arrow ›

Lower-risk recall

Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

Take action

Contact the company

Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607

✎ GovInfoNow plain-language explainer

Arrow is recalling certain central line catheter kits because they don't include essential safety checklists for medical procedures. This could lead to errors during critical insertions if used without the checklist. Read more at govinfonow.com/recall/72538-arrow-cvc-kit-lacks-safety-checklist-recall-for-central-line.

Source Summary by GovInfoNow · govinfonow.com/recall/72538-arrow-cvc-kit-lacks-safety-checklist-recall-for-central-line · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1166-2018

Cite this page

“Arrow CVC Kit Lacks Safety Checklist: Recall for Central Line Insertion.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72538-arrow-cvc-kit-lacks-safety-checklist-recall-for-central-line. Based on FDA recall #Z-1166-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1166-2018%22&limit=1).

The FDA announced on November 14, 2017, that Arrow International Inc. is recalling the ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit because the products lack the required Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.

How to tell if you have it

Brand: Arrow
Product: ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit
Codes: CDC-42703-P1A, CDC-45703-P1A, 13F16H0215, 13F16H0216, 13F16J0157, 13F16J0053, 13F16J0182, 13F16J0186, 13F16K0119, 13F16K0266
Distribution: Nationwide

The hazard

According to the FDA, the recalled kits do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which are tools intended to guide clinicians in best practices during central line insertions.

Context

GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since June 1, 2017. Other recent recalls of similar products include Arrow Arterial Kits and Trays (July 26, 2024), Arrow Ultra 8 IAB Catheter Kit (April 29, 2024), and ARROW QuickFlash Radial Artery Catheter (February 12, 2024). Additional recent recalls include Arrow CVC Kits due to possible sterility issues (April 21, 2026), Arrow Pressure Injectable Catheters regarding incorrect adhesive manufacturing (March 11, 2026), and Arrow CVC Kits for risk of serious injuries from contaminated medication (April 21, 2026).

How to tell if you have this one

Check for model numbers: CDC-42703-P1A, CDC-45703-P1A, 13F16H0215, 13F16H0216, 13F16J0157, 13F16J0053, 13F16J0182, 13F16J0186, 13F16K0119, 13F16K0266. These kits were sold for medical use.

Brand
Arrow
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide Distribution

Recall number	Product, codes & lots
Z-1158-2018	Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.; ASK-09903-ECL 23F16H0387 23F16H0595
Z-1159-2018	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the central circulation.; ASK-15703-PWBH 13F16K0166
Z-1160-2018	Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.; ASK-29803-SJH 13F16K0136
Z-1161-2018	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Permits venous access to central circulation.; ASK-42703-PSCH 23F16H0492
Z-1162-2018	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.; ASK-45703-PNCB 23F16H0802
Z-1163-2018	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulation.; ASK-45703-PUR1 23F16H0385
Z-1164-2018	Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.; ASK-45802-PHMW 13F16K0236
Z-1165-2018	Pressure Injectable Multi- Lumen CVC Kit; CDC-15703-P1A 13F16J0336
Z-1166-2018	ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.; CDC-42703-P1A CDC-45703-P1A 13F16H0215 13F16H0216 13F16J0157 13F16J0053 13F16J0182 13F16J0186 13F16K0119 13F16K0266

Based on the official FDA remedy

What to do — step by step

Check Kit Model Numbers
Look for specific model numbers listed in the recall notice to confirm if your kit is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Nov 14, 2017Firm started the recall
Mar 22, 2018FDA classified it Class II
Mar 28, 2018Published in FDA’s Enforcement Report
Jul 15, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this a safety hazard?

The recall indicates a potential for errors during procedures due to missing safety checklists, but the risk level is low as the hazard is not described as causing serious injury in normal use.

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Link to this recall

<a href="https://govinfonow.com/recall/72538-arrow-cvc-kit-lacks-safety-checklist-recall-for-central-line">Arrow CVC Kit Lacks Safety Checklist: Recall for Central Line Insertion (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1166-2018 (November 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1166-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.