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U.S. Department of Health and Human Services

Class 2 Device Recall 10F Bioflex Tesio Kit

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  Class 2 Device Recall 10F Bioflex Tesio Kit see related information
Date Initiated by Firm September 02, 2009
Date Posted November 10, 2009
Recall Status1 Terminated 3 on April 16, 2010
Recall Number Z-0161-2010
Recall Event ID 53136
510(K)Number K971925  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box.

Hemodialysis catheter insertion kits.
Code Information Lot Number: MAVV890, exp 2014/07.
Recalling Firm/
Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact Susan Smith
Manufacturer Reason
for Recall
mislabeled as right are actually left
FDA Determined
Cause 2
Employee error
Action Medcomp issued a "Product Alert" letter dated September 2, 2009 to all customers informing them of the problem and the need to return the product. For further information, contact Medcomp at 215-256-4201.
Quantity in Commerce 100 trays
Distribution Worldwide Distribution -- United States (AR, FL, KS, LA, MO, PA, TN, and TX) and Austria.
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 = MEDICAL COMPONENTS, INC.