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Recall Observatory FDA recall evidence

Device product

1) 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

Z-1690-2016

March 18, 2016

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 73691
Status
Terminated
Classification
Class II
Quantity
1,305,150 units
Official record key
device-enforcement:Z-1690-2016

Official wording

Reason: The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.

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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.