| Class 2 Device Recall | |
Date Initiated by Firm | July 11, 2003 |
Date Posted | October 15, 2003 |
Recall Status1 |
Terminated 3 on April 12, 2004 |
Recall Number | Z-0020-04 |
Recall Event ID |
27131 |
510(K)Number | K934382 K960616 |
Product Classification |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered - Product Code GCY
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Product | Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah. |
Code Information |
lots 50905127 and 50905036. |
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 |
Manufacturer Reason for Recall | The suction valve may become stuck in the 'suction on' position under vacuum. |
FDA Determined Cause 2 | Other |
Action | A request for product return was sent to each customer beginning on July 11, 2003. |
Quantity in Commerce | 252 |
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
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