Lower risk Medical device recall · FDA · Published November 27, 2017

Arrow CVC Kit Missing Label Recall: Check for Lot Number Sticker

Arrow recalls some CVC kits for missing lot number and expiration stickers. Check your kit for a sticker with lot number, expiration date, and UDI. Contact Arrow for details.

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

🇺🇸 FDA recall #Z-1004-2018Medical device Arrow ›

Lower-risk recall

Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Arrow is recalling certain CVC kits that may be missing a sticker with lot number, expiration date, and UDI information. This could affect medical use as the sticker is needed for tracking and safety. Read more at govinfonow.com/recall/72476-arrow-cvc-kit-missing-label-recall-check-for-lot-number.

Source Summary by GovInfoNow · govinfonow.com/recall/72476-arrow-cvc-kit-missing-label-recall-check-for-lot-number · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1004-2018

Cite this page

“Arrow CVC Kit Missing Label Recall: Check for Lot Number Sticker.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72476-arrow-cvc-kit-missing-label-recall-check-for-lot-number. Based on FDA recall #Z-1004-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1004-2018%22&limit=1).

The FDA announced on November 27, 2017, that Arrow International Inc. is voluntarily recalling ARROWg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kits because some units may lack a sticker containing lot number, expiration date, and Unique Device Identification information.

How to tell if you have it

Brand: Arrow
Product: ARROWg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kit
Model numbers: CDA-42802-P1A, CDA-42854-P1A, CDA-45703-P1A, CDA-47702-P1A
Lot codes: 13F16K0239, 13F16L0285, 13F17C0318, 13F16L0071, 13F16M0048, 13F17E0124, 13F17F0497, 13F17G0428, 13F17H0387, 13F16K0306, 13F16L0091, 13F17A0167, 13F17B0145, 13F17C0174, 13F17C0466, 13F17E0095, 13F17F0261, 13F17G0090, 13F17G0541, 13F17H0566, 13F17B0249
Units affected: 23,904

The hazard

According to the FDA, some of the recalled products may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

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 UltraFlex Intra-Aortic Balloon Catheter Kit (April 29, 2024), and ARROW QuickFlash Radial Artery Catheter (February 12, 2024). Additional recent recalls of similar products include Arrow CVC Kits (April 21, 2026), Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit (March 11, 2026), and Arrow PICC Kits (April 21, 2026).

How to tell if you have this one

Check the kit for a sticker with the lot number, expiration date, and UDI information. The affected kits include specific model numbers listed in the recall notice.

Brand
Arrow
Category
Medical device

FDA recall event · 12 products

All 12 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
US in the states of OH, FL, SC, TX, KY, NJ, MI

Recall number	Product, codes & lots
Z-0994-2018	Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; ASK-12703-PRJ 13F17B0279 13F17D0112 ASK-15703-PRJ 13F17B0265
Z-0995-2018	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; ASK-42703-PRJ 13F16L0007 13F16M0013 13F17A0296 13F17D0110 13F17F0319
Z-0996-2018	Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; ASK-45552-RWJ4 13F16J0286 13F16L0014 13F17A0217 13F17D0222 13F17E0849 13F17F0784 13F17G0413
Z-0997-2018	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI. Catheter and Sharps Safety Features; ASK-45703-PRJ 13F16M0019 13F17B0343 13F17D0113 13F17G0059 13F17H0095
Z-0998-2018	AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; CA-42703-P1A 13F16M0047 13F17B0152 13F16K0302 13F17F0226 13F17H0407 13F17A0157 13F17B0117 13F17C0250 13F17F0259 13F17H0100 13F17C0057 13F17F0298 13F17H0068
Z-0999-2018	AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; CA-45854-P1A 13F17F0071
Z-1000-2018	ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; CDA-21242-1A 13F16L0209 13F17F0437
Z-1001-2018	ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; CDA-22123-1A 13F17F0744
Z-1002-2018	ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; CDA-29803-1A 13F16M0122 13F17C0267 13F17E0385 13F17G0192
Z-1003-2018	AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; CDA-42703-P1A 13F16L0092 13F17A0022 13F17A0301 13F17C0266 13F17D0039 13F17F0299 13F17H0071
Z-1004-2018	ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; CDA-42802-P1A CDA-42854-P1A CDA-45703-P1A 13F16K0239 13F16L0285 13F17C0318 13F16L0071 13F16M0048 13F17E0124 13F17F0497 13F17G0428 13F17H0387 13F16K0306 13F16L0091 13F17A0167 13F17B0145 13F17C0174 13F17C0466 13F17E0095 13F17F0261 13F17G0090 13F17G0541 13F17H0566 CDA-47702-P1A 13F17B0249
Z-1005-2018	ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.; CDA-45854-P1A 13F17C0325 13F17D0283 13F17F0748

Based on the official FDA remedy

What to do — step by step

Check for Sticker
Look for a sticker with the lot number, expiration date, and UDI information on the kit.

Where it went and when

Where it was distributed

Distributed in 7 states.

FDA distribution: “US in the states of OH, FL, SC, TX, KY, NJ, MI” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Kentucky, Michigan, New Jersey, Ohio, South Carolina, Texas.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Nov 27, 2017Firm started the recall
Mar 13, 2018FDA classified it Class II
Mar 21, 2018Published in FDA’s Enforcement Report
Sep 22, 2020FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/72476-arrow-cvc-kit-missing-label-recall-check-for-lot-number">Arrow CVC Kit Missing Label Recall: Check for Lot Number Sticker (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-1004-2018 (November 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1004-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.