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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun Introcan Safety IV Catheters

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  Class 2 Device Recall B. Braun Introcan Safety IV Catheters see related information
Date Initiated by Firm March 23, 2020
Create Date November 30, 2020
Recall Status1 Open3, Classified
Recall Number Z-0509-2021
Recall Event ID 86680
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01
4252519-01
4252535-01
4252560-01
4252586-01
4251890-01
4252535-01
4252586-01
4251644-01
Code Information Lots  T-18L23G8271 T-17A20G8273 T-18M02G8315 NT-16H16G8261 T-18K18G8244 T-17D08G8241 NT-1 6H16G8261  15H25G8315 18G15A272 18G31G8316 18G31G8392 17H20G8391  18M02G8315 18M02G8315 18F29G8362 18D01G8273 17K08G8272 17K08G8273 17G10G8261  19A12G8272 19A12G8272 18H17G8272 18H17G8272 18F26G8303 18H04G8261 15F25G8395 17K27G8304 17C16G8304 17H02G8392 17F15G8302 17M10G8271 17M10G8273 17M15G8261 17C17G8302 17C18G8305  18M20G8271 18L29G8271 18K08G8263 18HI8G8243 18F25G8272 18F25G8272 17M11G8273 17H23G8272 17H23G8271 17H23G8271  18L23G8271 18L23G8271 17A20G8273 17A20G873 17A20G8273  17D08G8241 17D08G8241 17D08G8241  16N24G8303 16H30G8303 16H30G8304 16L0G8275  14N10G8274  16H16G8261  
Recalling Firm/
Manufacturer
Janus Trade Group
556 Industrial Way W
Eatontown NJ 07724-4236
Manufacturer Reason
for Recall
Distribution of unauthorized B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG. Secondly, JTG is not an authorized distributor of this product within the United States. Lastly the device has incorrect labeling.
FDA Determined
Cause 2
No Marketing Application
Action Between March 13-25, 2020, Janus Trade Group made phone contact with customers requesting to check if customers had product on hand. If customers had product on hand, they were asked to send it back to JTG for a full refund.
Quantity in Commerce 1365 cases (200 units/case)
Distribution US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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