BD Insyte Autoguard Shielded IV Catheter needle retraction failure
Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (20 GA x 1.16 in, REF 381434) because the catheter needle may be slow to retract or fail to retract entirely.
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: This is an FDA Class II recall involving a risk-of-harm product (needle retraction failure) where no injuries have been reported to date. According to the rubric, risk-of-harm products without reported injury typically score 3 (High).
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling the BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm), 60 mL/min, reference number 381434, lot number 4116814, UDI 00382903814343. The recall affects 50 units distributed worldwide, including throughout the United States and internationally to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam.
Due to customer complaints, there is the possibility that the catheter needle may be slow to retract or fail to retract. This is a Class II medical device recall.
Patients and healthcare providers who have this product should contact Becton Dickinson Infusion Therapy Systems, Inc. for further instructions and potential replacement options.
The recalled product
- Product
- REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- Category
- Medical Device — IV Catheter
- Hazard
- needle-retraction-failure
- injury-risk
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 (1)
- Lot# 4116814/ UDI: 00382903814343
Distribution
Distributed nationwide across the United States.
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