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U.S. Department of Health and Human Services

Class 2 Device Recall PORTACATH II POWER P.A.C. Low Profile" system.

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  Class 2 Device Recall PORTACATH II POWER P.A.C. Low Profile" system. see related information
Date Initiated by Firm June 11, 2020
Create Date July 04, 2020
Recall Status1 Terminated 3 on January 25, 2021
Recall Number Z-2499-2020
Recall Event ID 85847
510(K)Number K072657  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
Code Information Lot 3921849.
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave Halverson
763-383-3072
Manufacturer Reason
for Recall		 Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
FDA Determined
Cause 2		 Under Investigation by firm
Action Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter.
Quantity in Commerce 46 kits
Distribution Domestic Distribution: AR, CT, MS,TN,TX
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 = SMITHS MEDICAL MD, INC.
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