Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1007-2018 · Posted None

Recalling FirmMedtronic Minimally Invasive Therapies Group
Recall StatusTerminated
Product CodeMPB
Date Initiated2017-10-14
Date Terminated2018-06-15

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.

Firm Action

Medtronic began notifying customers via telephone on October 14, 2017, and all consignees were notified via Federal Express or certified mail on October 17, 2017. The letter informs customers that they were shipped devices that were not sterile. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.

Root Cause

Process control

Distribution Pattern

U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120674MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETERCovidien · 2012-04-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑