Agency classClass IIOur severity:High FDA (Devices)·Z-0572-2015·Announced 2014-12-17

BD Insyte Autoguard Catheter Recall for Potential Body Damage

Becton Dickinson is recalling BD Insyte Autoguard catheters due to potential damage along the catheter body.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a medical device with a structural defect (damage along the catheter body) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling BD Insyte Autoguard Catheters. These are active safety engineered peripheral IV catheters with a retracting needle designed to reduce accidental needle stick injuries. The recall is being conducted because the devices may have potential damage along the body of the catheter.

The affected products were distributed worldwide, including nationwide in the United States and internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste. The recall covers approximately 296,800 devices in the US and 3,250,150 devices outside the US. Specific lot numbers and expiration dates are listed in the agency's recall record.

Healthcare providers and facilities should stop using the affected devices and contact Becton Dickinson for instructions on how to return or dispose of them.

The recalled product

Product: 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…
Manufacturer: Becton Dickinson & Company
Category: Medical Device — IV Catheter
Hazard: structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

Exp May-17
4161662
Jun-17
4164960
4167812
4174713
4182668
Apr-17
4107722
4113707
4113713
May-17
4119730
4129576
4147742

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Becton Dickinson & Company

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