Data Foundry

Medical device recalls 2014

Hudson RCI — Class II medical device recall Z-2107-2014

Terminated recall by Teleflex Medical, reported 2014-07-30, distributed in CA, FL, KS, KY, MA, MI, MO, NC…. The temperature probe does not properly connect to the temperature port.

Recall numberZ-2107-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTeleflex Medical, Durham, NC, United States
Recall initiated2014-07-09
Classified2014-07-23
Reported by FDA2014-07-30
Terminated2017-03-09
DistributedCA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX, VA
Countries outside the USAR, CL, CO, PH
Quantity11,679 units
Lot numbers02A140133, 02L1300073
Model numbers780-96

Product

Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.

Reason for recall

The temperature probe does not properly connect to the temperature port.

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-2107-2014. 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.