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Class 2 Device Recall QPC1680 Quick Connect |
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Date Initiated by Firm |
March 15, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on May 18, 2004 |
Recall Number |
Z-0765-04 |
Recall Event ID |
28569 |
510(K)Number |
k875280
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Product Classification |
Sterilant, Medical Devices - Product Code MED
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Product |
QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680 |
Code Information |
Lots #2925196, #2911782, #2925238. |
Recalling Firm/ Manufacturer |
Steris Corp 5960 Heisley Rd Mentor OH 44060-1834
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For Additional Information Contact |
440-392-7019
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Manufacturer Reason for Recall |
A defective port adapter may affect the sterilization process of the attached endoscope.
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FDA Determined Cause 2 |
Process control |
Action |
The firm contacted the consignees by letter and in person. |
Quantity in Commerce |
40 units |
Distribution |
The product was shipped to domestic consignees in LA, NC, OH, CT, VA, CA, ME, MD, IL, PA, SC, WY, ND, NY, OK, TX. Foreign distribution involves: Canada, Italy, and Germany. |
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 = MED and Original Applicant = STERIS C/O MEDICAL DEVICE CONSULTANTS, INC.
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