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U.S. Department of Health and Human Services

Class 2 Device Recall Tracheobronchial suction catheter.

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  Class 2 Device Recall Tracheobronchial suction catheter. see related information
Date Initiated by Firm June 13, 2003
Date Posted August 06, 2003
Recall Status1 Terminated 3 on November 24, 2003
Recall Number Z-1082-03
Recall Event ID 26542
510(K)Number K872621  
Product Classification Catheters, Suction, Tracheobronchial - Product Code BSY
Product Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates
Code Information Catalog No: 1930, Lot Numbers: 212853, 213673, 213675, 217882.
Recalling Firm/
Ballard Medical Products
12050 S Lone Peak Parkway
Draper UT 84020
For Additional Information Contact
Manufacturer Reason
for Recall
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
FDA Determined
Cause 2
Action All consignees were notified by letter on 06/13/2003.
Quantity in Commerce 1705 units
Distribution Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom.
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 = BSY and Original Applicant = BALLARD MEDICAL PRODUCTS