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U.S. Department of Health and Human Services

Class 2 Device Recall Introducer catheter

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  Class 2 Device Recall Introducer catheter see related information
Date Initiated by Firm January 10, 2005
Date Posted March 18, 2005
Recall Status1 Terminated 3 on April 12, 2005
Recall Number Z-0628-05
Recall Event ID 30864
510(K)Number K941428  
Product Classification Introducer, Catheter - Product Code DYB
Product BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray
Code Information Ref. No. 680124, Lot No''s. 406462 and 311197
Recalling Firm/
Becton Dickinson Infusion Therapy
9450 S State St
Sandy UT 84070
For Additional Information Contact
Manufacturer Reason
for Recall
Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
FDA Determined
Cause 2
Action Customers were contacted by telephone and by letters dated 01/10/05.
Quantity in Commerce 15 units
Distribution Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.
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 = DYB and Original Applicant = OHMEDA MEDICAL