IV Catheter Recall: BD Insyte Autoguard Needle Retraction Failure
Becton Dickinson is recalling the BD Insyte Autoguard Shielded IV Catheter (Ref 381434) due to customer complaints that the catheter needle may be slow to retract or fail to retract. No illnesses or injuries have been reported.
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: FDA Class II device recall with no reported illnesses or injuries. The hazard—potential needle retraction failure on an IV catheter safety mechanism—poses a risk of harm but is currently theoretical, meeting the criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling the BD Insyte Autoguard Shielded IV Catheter, model REF 381434 (20 GA x 1.16 in, 60 mL/min). The affected lot is identified as 4116814, with UDI 00382903814343.
The recall was initiated due to customer complaints indicating that the catheter needle may be slow to retract or fail to retract. This needle retraction mechanism is a critical safety feature designed to prevent needle-stick injury during clinical use.
The product was distributed worldwide, including throughout the United States and to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam.
Healthcare providers and facilities who have received this product should verify their inventory and contact Becton Dickinson or their supplier for further guidance regarding affected units.
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
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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