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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
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  
Product Classification Apparatus, Suction, Single Patient Use, Portable, Nonpowered - Product Code GCY
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/
Vital Concepts, Inc.
5090 Kendrick Ct. S E
Grand Rapids MI 49512
For Additional Information Contact
Manufacturer Reason
for Recall
The suction valve may become stuck in the 'suction on' position under vacuum.
FDA Determined
Cause 2
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

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 = GCY and Original Applicant = VITAL CONCEPTS, INC.