Reported Aug 22, 2018 · Terminated

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath…

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 · 2400 Bernville Rd · Reading, PA · 19605-9607

Is this the product you have?

  • 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.
Lot codes and dates
    • 14F15F0156
    • 14F15H0228
    • 14F15K0746
    • 14F16B0085
    • 14F16D0424
    • 14F16F0700
    • 14F16G0471
Amount recalled
7024 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 27, 2020 · Data as of Sep 19, 4:47 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.