RecallRadar

FDA Device recall Z-2606-2018

119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile…

On 2018-08-15 the FDA classified a Class II recall of 119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile… by Icu Medical, citing some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2606-2018
ClassificationClass II
Statusterminated
Initiated2017-07-31
Published2018-08-15
Last updated2026-09-13 11:54 UTC
CompanyIcu Medical
DistributionUS

Product

119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Reason

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Identifiers

code_infoItem Number 011-C6000, Lot Number 3422869

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2606-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.