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Class 2 Device Recall |
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Date Initiated by Firm |
July 11, 2003 |
Date Posted |
October 15, 2003 |
Recall Status1 |
Terminated 3 on April 12, 2004 |
Recall Number |
Z-0025-04 |
Recall Event ID |
27131 |
510(K)Number |
K934382 K960616
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Product Classification |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered - Product Code GCY
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Product |
Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing, Disposable (single use only), sterile, latex free. Catalog # 55050. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. |
Code Information |
lots 50904971 and 50905123. |
Recalling Firm/ Manufacturer |
Vital Concepts, Inc. 5090 Kendrick Ct. S E Grand Rapids MI 49512
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For Additional Information Contact |
616-954-2890
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Manufacturer Reason for Recall |
The suction valve may become stuck in the 'suction on' position under vacuum.
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FDA Determined Cause 2 |
Other |
Action |
A request for product return was sent to each customer beginning on July 11, 2003. |
Quantity in Commerce |
120 |
Distribution |
Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan |
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 = GCY and Original Applicant = VITAL CONCEPTS, INC.
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