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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-0021-04 |
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 with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec. |
Code Information |
lots 50904840, 50904918, 50904919, 50904935, 50904958, 50904959, 50904988, 50904994, 50905033, 50905050A, 50905093, 50905121 and 50905148. |
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 |
2333 |
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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