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U.S. Department of Health and Human Services

Class 2 Device Recall PORTACATH

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  Class 2 Device Recall PORTACATH see related information
Date Initiated by Firm December 04, 2017
Date Posted March 15, 2018
Recall Status1 Terminated 3 on June 12, 2020
Recall Number Z-1073-2018
Recall Event ID 79429
510(K)Number K973862  K974471  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as:

a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA);
b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA);
c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
Code Information a. Item No. 21-4071-24 (Lot No. 86X046, 87X050);  b. Item No. 21-8066-24 (Lot No. 87X178);  c. Item No. 21-8068-24 (Lot No. 87X179)
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact
763-383-3072
Manufacturer Reason
for Recall		 Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.
FDA Determined
Cause 2		 Process design
Action Customers were notified via letter on about 12/04/2017. Instructions include to examine current inventory for affected product, collect and isolate any potentially affected product, determine the total number of potentially affected product in possession and complete and return the Urgent Medical Device Recall Response Form, return any affected product on hand, and notify customers if the affected products were further distributed.
Quantity in Commerce 1,077 units total
Distribution Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
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 = LJT and Original Applicant = SIMS DELTEC, INC.
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