Data Foundry

Medical device recalls 2015

107" — Class II medical device recall Z-1589-2015

Terminated recall by ICU Medical, Inc., reported 2015-05-13, distributed nationwide. ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that

Recall numberZ-1589-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmICU Medical, Inc., San Clemente, CA, United States
Recall initiated2015-04-20
Classified2015-05-07
Reported by FDA2015-05-13
Terminated2015-11-24
DistributedNationwide (US)
Quantity600 units
Reason classespackaging
Lot numbers2995225, 3002665, 3004236
Model numbersB33041

Product

107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Reason for recall

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1589-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.