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Class 2 Device Recall 10F Bioflex Tesio Kit |
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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
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Product Classification |
Catheter, hemodialysis, implanted - Product Code MSD
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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
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For Additional Information Contact |
Susan Smith 215-256-4201
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Manufacturer Reason for Recall |
mislabeled as right are actually left
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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
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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.
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510(K) Database |
510(K)s with Product Code = MSD and Original Applicant = MEDICAL COMPONENTS, INC.
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