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.
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: 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
- Affected units
- 50
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
Part of a larger recall action
This product is one of 9 recalled by Becton Dickinson Infusion Therapy Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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