The Recall Desk
HighFDA (Devices)·Z-1690-2016·Announced 2016-05-25

Becton Dickinson Recalls Shielded IV Catheters Due to Defect

Becton Dickinson is recalling 1.3 million shielded IV catheters because a defect could cause the catheter to separate or break.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (catheter breakage) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Becton Dickinson & Company is recalling approximately 1,305,150 units of BD Angiocath Autoguard shielded IV catheters. The affected products include the 24 G x 0.75 in. (catalog number 381700) and 24 G x 0.56 in. (catalog number 381720) models, which are made of FEP polymer. These devices were distributed nationwide.

The recall is being conducted because the devices may have a defect in the catheter. In some instances, this defect could result in catheter separation or breakage. The source text does not specify the exact nature of the defect or report any specific injuries or illnesses associated with the use of these devices.

Healthcare facilities and consumers who have these specific catalog numbers and lot codes should stop using the affected catheters and contact Becton Dickinson for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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
Affected units
1,305,150

Distribution

Distributed nationwide across the United States.

Same hazard · catheter breakage

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