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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 cathetersee related information
Date Initiated by FirmFebruary 03, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 10, 2004
Recall NumberZ-0587-04
Recall Event ID 28397
510(K)NumberK974764 
Product Classification Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
ProductBD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
Code Information Catalog Number 380402, Lot Numbers 3356877, 3356485, 3352218.
Recalling Firm/
Manufacturer
Becton Dickinson Infusion Therapy
9450 South State Street
Sandy UT 84070
For Additional Information Contact
801-565-2341
Manufacturer Reason
for Recall
Splittable catheter introducer may not fully split or may separate non-uniformly.
FDA Determined
Cause 2
Other
ActionOn 02/03/2004, all consignees were notified by telephone and letter.
Quantity in Commerce12000 units
DistributionNationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FOZ
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