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U.S. Department of Health and Human Services

Class 2 Device Recall BD Angiocath Autoguard shielded IV catheter

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 Class 2 Device Recall BD Angiocath Autoguard shielded IV cathetersee related information
Date Initiated by FirmMarch 18, 2016
Date PostedMay 18, 2016
Recall Status1 Terminated 3 on July 19, 2017
Recall NumberZ-1690-2016
Recall Event ID 73691
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720
Code Information Catalog Number 381720 - 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer.   3121951 3143801 3190895 3254585 3303872 4051735 4133600 4177944 4219570 4289603 4317642 5063833 5106687 5125665 5230884 5300771     24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer  3045792 3106688 3289840 4059581 4203557 5002915 5063827 5125565 5300772 
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactMs. Zuleika S¿nchez
201-847-6800
Manufacturer Reason
for Recall		The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.
FDA Determined
Cause 2		Device Design
ActionBD isssued an urgent voluntary product recall lettter/recall response card on 3/18/2016.
Quantity in Commerce1,305,150 units
DistributionNationwide
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.
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