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[Recalled] 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, st

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Product105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tub
Brand / manufacturerICU Medical, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2635-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date31 July 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from ICU Medical, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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