Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MAHURKAR" Elite 12 FR x 16cm Acute Dual Lumen Dialysis

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MAHURKAR" Elite 12 FR x 16cm Acute Dual Lumen Dialysissee related information
Date Initiated by FirmOctober 14, 2017
Create DateMarch 14, 2018
Recall Status1 Terminated 3 on June 15, 2018
Recall NumberZ-1007-2018
Recall Event ID 79319
510(K)NumberK120674 
Product Classification Catheter, hemodialysis, non-implanted - Product Code MPB
ProductMAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Code Information UDI: 10884521126473/20884521126470 Lot: 1717900160.
FEI Number 1282497
Recalling Firm/
Manufacturer		 Medtronic Minimally Invasive Therapies Group
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact
508-261-8000
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionMedtronic 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.
DistributionU.S.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MPB
-
-