BD Insyte Autoguard BC Pro Winged Shielded IV Catheter Needle Retraction Issue
Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (18 GA x 1.16 in, Lot 4208538) due to reports that the catheter needle may be slow to retract or fail to retract completely.
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 of a medical device with a risk-of-harm hazard (needle retraction failure on an IV catheter) where injury has not yet been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling the BD Insyte Autoguard BC Pro Winged Shielded IV Catheter (Reference 381811, 18 GA x 1.16 in, 1.3 x 30 mm, 95 mL/min) due to customer complaints that the catheter needle may be slow to retract or fail to retract.
The affected lot is 4208538 (UDI: 00382903818112), distributed worldwide including throughout the United States and to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam.
Patients and healthcare providers who have this product should discontinue use. Healthcare facilities should contact Becton Dickinson for further guidance on handling existing inventory and patient notifications.
The recalled product
- Product
- REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- Category
- Medical Device — IV Catheter
- Hazard
- needle-retraction-failure
- needlestick-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# 4208538/UDI: 00382903818112
Distribution
Distributed nationwide across the United States.
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