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Lower risk Medical device recall · FDA · Published January 10, 2019

Arrow Two-Lumen Catheter Set Recall: Incorrect Priming Volume Labeling

Arrow recalls two-lumen central venous catheter sets with blue flextip catheters due to incorrect priming volume labeling on the lidstock. This may cause errors in medical procedures.

🇺🇸 FDA recall #Z-1119-2019Medical deviceArrow ›
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Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
✎ GovInfoNow plain-language explainer

Arrow is recalling two-lumen central venous catheter sets with blue flextip catheters because the lidstock labels show the wrong priming volume. This could lead to medical errors during procedures if healthcare providers rely on the incorrect volume. Read more at govinfonow.com/recall/69138-arrow-two-lumen-catheter-set-recall-incorrect-priming-volume-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/69138-arrow-two-lumen-catheter-set-recall-incorrect-priming-volume-labeling · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1119-2019

Cite this page

“Arrow Two-Lumen Catheter Set Recall: Incorrect Priming Volume Labeling.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69138-arrow-two-lumen-catheter-set-recall-incorrect-priming-volume-labeling. Based on FDA recall #Z-1119-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1119-2019%22&limit=1).

The FDA announced on Jan. 10, 2019, that Arrow International Inc. is recalling its Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter due to a labeling error on the lidstock stating an incorrect priming volume. The agency issued recall number Z-1119-2019 for the Class II device.

How to tell if you have it

  • Brand: Arrow
  • Product: Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter
  • Product Code: CD-10802
  • GTN: 00801902015396
  • Lot Numbers (US): 71F15J1055, 71F15K0223, 71F15D1461, 71F18A1856
  • Lot Numbers (Worldwide): 71F14H0908, 71F15K0223, 71F16M1878, 71F18A0343, 71F14J0958, 71F15L0155, 71F17A0524, 71F18A1856, 71F14J1954, 71F15L1514, 71F17A1118, 71F18B0295, 71F14J1955, 71F15M0771, 71F17A1119, 71F18B3053, 71F14K1117, 71F16A0286, 71F17A2452, 71F18C0752, 71F14L0040, 71F16A1142, 71F17C0184, 71F18C1686, 71F14L0813, 71F16B0097, 71F17C0408, 71F18C2250, 71F14M0892, 71F16B1126, 71F17C2294, 71F18C3030, 71F14M1389, 71F16B2212, 71F17C2749, 71F18C3042, 71F15A0039, 71F16C1127, 71F17D0329, 71F18D2222, 71F15D1461, 71F16D1063, 71F17E1237, 71F18E1357, 71F15E1320, 71F16E0976, 71F17E2316, 71F18E1753, 71F15F1005, 71F16F0403, 71F17F0829, 71F18F2625, 71F15F1955, 71F16F1512, 71F17G1171, 71F18G0263, 71F15G0461, 71F16G0246, 71F17G1628, 71F18G2183, 71F15G1764, 71F16H0027, 71F17H2043, 71F18H0650, 71F15H0569, 71F16H0595, 71F17J0668, 71F18H1673, 71F15H1347, 71F16L0623, 71F17L1848, 71F18J0116, 71F15J0063, 71F16L1734, 71F17M1416, 71F15J1055, 71F16M0795, 71F17M1978
  • Quantity: 45 eaches total (US)
  • Distribution: FL, NC

The hazard

According to the FDA, the product lidstock contains a labeling error stating an incorrect priming volume. The record notes that the priming volumes printed on the extension lines are correct.

Context

GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since June 1, 2017. Recent brand recalls include Arrow Arterial Kits and Trays (July 26, 2024) regarding open seals and Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (April 29, 2024) involving potential serious health consequences. Other recent recalls of similar products include Arrowg+ard Blue MAC Two-Lumen Catheter Kit (March 11, 2026), Arrow Pressure Injectable Catheters (March 11, 2026), and Arrow MAC Two-Lumen Central Venous Access Kit (March 11, 2026), all citing incorrect adhesive manufacturing.

How to tell if you have this one

Look for the Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter. Product code CD-10802 with lot numbers listed in the recall notice. The lidstock shows the incorrect priming volume.

  • Brand
    Arrow
  • Category
    Medical device
FDA recall event · 2 products

All 2 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
    FL, NC
Recall numberProduct, codes & lotsQuantity
Z-1118-2019Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132; Lot Numbers: 71F14E0696 71F14K0658 71F15E0493 71F15L0621 71F14E1541 71F14K1683 71F15F0090 71F15M0787 71F14F1154 71F14L0719 71F15H0574 71F16A0278 71F14H0474 71F14M1375 71F15H1503 71F16B0054 71F14H1215 71F15A0025 71F15J0570 71F16B1306 71F14J0852 71F15A1592 71F15J2098 71F14J1889 71F15D1460 71F15L0153None (US)
Z-1119-2019Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396; Lot Numbers: US: 71F15J1055 71F15K0223 71F15D1461 71F18A1856 Worldwide: 71F14H0908 71F15K0223 71F16M1878 71F18A0343 71F14J0958 71F15L0155 71F17A0524 71F18A1856 71F14J1954 71F15L1514 71F17A1118 71F18B0295 71F14J1955 71F15M0771 71F17A1119 71F18B3053 71F14K1117 71F16A0286 71F17A2452 71F18C0752 71F14L0040 71F16A1142 71F17C0184 71F18C1686 71F14L0813 71F16B0097 71F17C0408 71F18C2250 71F14M0892 71F16B1126 71F17C2294 71F18C3030 71F14M1389 71F16B2212 71F17C2749 71F18C3042 71F15A0039 71F16C1127 71F17D0329 71F18D2222 71F15D1461 71F16D1063 71F17E1237 71F18E1357 71F15E1320 71F16E0976 71F17E2316 71F18E1753 71F15F1005 71F16F0403 71F17F0829 71F18F2625 71F15F1955 71F16F1512 71F17G1171 71F18G0263 71F15G0461 71F16G0246 71F17G1628 71F18G2183 71F15G1764 71F16H0027 71F17H2043 71F18H0650 71F15H0569 71F16H0595 71F17J0668 71F18H1673 71F15H1347 71F16L0623 71F17L1848 71F18J0116 71F15J0063 71F16L1734 71F17M1416 71F15J1055 71F16M0795 71F17M197845 eaches total (US)
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Verify the product code and lot numbers on the lidstock to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed in Florida and North Carolina.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

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

States: Florida, North Carolina.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Jan 10, 201912. FDA classified it Class II: Apr 10, 201923. Published in FDA’s Enforcement Report: Apr 17, 201934. FDA terminated the recall: Jun 4, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Are there any safety risks?

The recall is for labeling errors that could cause medical errors, but there is no immediate risk of injury or harm to users.

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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-1119-2019 (January 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1119-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA