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U.S. Department of Health and Human Services

Class 2 Device Recall Titan Hemodialysis Catheter

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  Class 2 Device Recall Titan Hemodialysis Catheter see related information
Date Initiated by Firm May 19, 2011
Date Posted June 28, 2011
Recall Status1 Terminated 3 on October 24, 2016
Recall Number Z-2693-2011
Recall Event ID 58975
510(K)Number K030502  
Product Classification Catheter, Hemodialysis, Implanted - Product Code MSD
Product THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit


Product Usage: Hemodialysis catheter insertion kit
Code Information Lot # MAZX990; Catalog # THD155428, Exp Date 2013/03
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact Susan Smith, RN BSN
215-256-4201 Ext. 225
Manufacturer Reason
for Recall		 Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Medcomp sent a "PRODUCT ALERT" letter dated May 19, 2011 to all affected customers. The letter described the product, problem, and actions to be taken. The letter is requesting the return of all affected product. Customers are instructed to contact their customer service representative for an RGA (returned good authorization) number. If you have any questions or concerns contact Medcomp at 215-256-4201 ext. 2225.
Quantity in Commerce 90
Distribution Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands
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 = MSD and Original Applicant = MEDCOMP
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