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U.S. Department of Health and Human Services

Class 2 Device Recall 9F Plastic Dual Port

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  Class 2 Device Recall 9F Plastic Dual Port see related information
Date Initiated by Firm January 28, 2015
Date Posted April 27, 2015
Recall Status1 Terminated 3 on January 06, 2017
Recall Number Z-1527-2015
Recall Event ID 70457
510(K)Number K000125  
Product Classification Port and catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
Code Information Model No. MR592090A, MR592090P; with Lot Nos.:  MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 EXP. DATE 10/28/2014, MBFC140 EXP. DATE 05/28/2016, MBGH020 EXP. DATE 08/28/2016, MBHS100 EXP. DATE 11/28/2016, MAKT130 EXP. DATE 04/28/2012, MBAQ860 EXP. DATE 07/28/2015, MBHP980 EXP. DATE 11/28/2016, MBKJ110 EXP. DATE 03/28/2017 
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact Customer Support
215-256-4201
Manufacturer Reason
for Recall		 The dual port with catheters was not covered under FDA clearance.
FDA Determined
Cause 2		 PMA
Action Sales reps were notified by email on/about January 28, 2015, and instructed to notify their medical facilities and provide the recall letter. This will be accomplished by either email, telephone, or visit. Every consignee will be requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received.
Quantity in Commerce 325
Distribution Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
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 = CLINICAL PLASTIC PRODUCTS SA
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