Reported Dec 17, 2014 · Terminated

BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce…

Becton Dickinson & Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton Dickinson & Company · 1 Becton Dr · Franklin Lakes, NJ · 07417-1815

Is this the product you have?

  • BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.
Lot codes and dates

8 of 8 products

Products covered by this recall
Model / numberProduct as published
38143320 G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65ml/min
Lot numbers 4139786, Exp May-17; 4161662, Jun-17; 4164960, Jun-17; 4167812, Jun-17; 4174713, Jun-17; 4182668, Jun-17; 4182668, Jul-17
38143420 G x 1.16 in. BD Insyte Autoguard 1.1 x 30 mm 60 ml/min
Lot numbers 4105724, Apr-17; 4107722, Apr-17; 4113707, Apr-17; 4113713, Apr-17 Distributed outside of USA
38183320G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65 ml/min
Lot4143917, May -17
381183420 G x 1.16 in. BD Insyte AUtoguard 1.1 x 30 mm 60ml/min
Lot numbers 4119700, May-17; 4119730, May-17; 4129576, May-17; 4147742, May-17; 4107722, Apr-17
Amount recalled
US- 296,800 devices; OUS - 3,250,150 devices

Why it was recalled

BD Insyte Autoguard may have potential damage along the body of the catheter.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 24, 2015 · Data as of Sep 19, 6:04 PM UTC

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