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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm August 06, 2015
Date Posted September 01, 2015
Recall Status1 Terminated 3 on June 29, 2017
Recall Number Z-2535-2015
Recall Event ID 71893
510(K)Number K060339  
Product Classification Saline, vascular access flush - Product Code NGT
Product MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray
Item Code: 8888103002HP

Product Usage:
Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Code Information Lot Numbers: 1504700146      
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Same
203-492-5000
Manufacturer Reason
for Recall		 Sterility may be compromised
FDA Determined
Cause 2		 Packaging process control
Action Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
Quantity in Commerce 569 kits
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NGT and Original Applicant = TYCO HEALTHCARE/KENDALL
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