Data Foundry

Medical device recalls 2018

MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with… — Class II medical device recall Z-1007-2018

Terminated recall by Medtronic Minimally Invasive Therapies Group, reported 2018-03-21. Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Cath

Recall numberZ-1007-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedtronic Minimally Invasive Therapies Group, Mansfield, MA, United States
Recall initiated2017-10-14
Classified2018-03-14
Reported by FDA2018-03-21
Terminated2018-06-15
UPC / GTIN / UDI-DI10884521126473, 20884521126470
Lot numbers1717900160

Product

MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

Reason for recall

Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.

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-1007-2018. 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.