Lower riskMedical device recall · FDA · Published July 10, 2018
Arrow Hands-Off Multi-Lumen Catheter Recall: Packaging Not Sealed
Arrow recalls Hands-Off Multi-Lumen Central Venous Catheters with Blue FlexTip due to potential packaging compromise affecting sterility. Affected models include HO-14703 and others listed. Contact Arrow for details.
“Arrow Hands-Off Multi-Lumen Catheter Recall: Packaging Not Sealed.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70647-arrow-hands-off-multi-lumen-catheter-recall-packaging-not-sealed. Based on FDA recall #Z-2819-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2819-2018%22&limit=1).
The FDA announced on July 10, 2018, that Arrow International Inc. is recalling HANDS-OFF Multi-Lumen Central Venous Catheters because the packaging may not be sealed, compromising sterility. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Arrow
Product: HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System
Material: HO-14703
Lot codes: 14F15G0105, 14F15H0230, 14F15L0085, 14F16A0438, 14F16C0142, 14F16D0060, 14F16F0046, 14F16F0564
Units: 5507
The hazard
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
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 FiberOptix Intra-Aortic Balloon Catheter Kit Recall (April 29, 2024), and ARROW QuickFlash Radial Artery Catheter Recall (Feb. 12, 2024).
How to tell if you have this one
Check for model numbers: HO-14703, 14F15G0105, 14F15H0230, 14F15L0085, 14F16A0438, 14F16C0142, 14F16D0060, 14F16F0046, 14F16F0564. These catheters are designed to work only with Arrow One-Piece Percutaneous Sheath Introducer Systems.
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
Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates and the United Kingdom.
Recall number
Product, codes & lots
Quantity
Z-2818-2018
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.; 14F15F0156, 14F15H0228, 14F15K0746, 14F16B0085, 14F16D0424, 14F16F0700, 14F16G0471
7024 units
Z-2819-2018
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.; 14F15G0105, 14F15H0230, 14F15L0085, 14F16A0438, 14F16C0142, 14F16D0060, 14F16F0046, 14F16F0564
5507 units
Based on the official FDA remedy
What to do — step by step
Check Packaging Seal
Look for signs that the packaging is not sealed properly, which could compromise sterility.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 26 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, California, Florida, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2819-2018 (July 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2819-2018 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.