Class 2 Device Recall 10F Bioflex Tesio Kit

• Date Initiated by Firm: September 02, 2009
• Date Posted: November 10, 2009
• Recall Status: Terminated 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/ Manufacturer: Medical Components, Inc dba MedComp; 1499 Delp Dr; Harleysville PA 19438
• For Additional Information Contact: Susan Smith; 215-256-4201
• Manufacturer Reason for Recall: mislabeled as right are actually left
• FDA Determined Cause: 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