Reported May 19, 2021 · Ongoing

REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the…

ICU Medical, 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: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212

Is this the product you have?

  • REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap
  • Vented Cap - Product Usageprovides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein)
Lot codes and dates
  • REFCH3034
  • UDI(01) 1 0840619 02411 3 (17) 260101 (30) 50 (10) 5125305
  • Lot Number5125305

This recall covers 26 products

The agency filed one notice per product. You are reading one of them; the other 25 are below.

13 more are in the archive.

Where it was sold

Why it was recalled

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

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

Data as of Sep 19, 7:39 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.