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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 November 07, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 13, 2004
Recall Number Z-0261-04
Recall Event ID 27694
510(K)Number K934382  K960606  
Product Classification Tube, Aspirating, Flexible, Connecting - Product Code BYY
Product Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand
Code Information lots 50904937 and 50904995.
Recalling Firm/
Vital Concepts, Inc.
5090 Kendrick Ct Se
Grand Rapids MI 49512-9649
For Additional Information Contact
Manufacturer Reason
for Recall
The probe may separate from the cannula.
FDA Determined
Cause 2
Action Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.
Quantity in Commerce 3045
Distribution Arizona, Illinois, Indiana, Michigan and Pennsylvania.
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 = BYY and Original Applicant = VITAL CONCEPTS, INC.