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.
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 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 superi
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — IV Catheter
- Hazard
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.
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