BD Insyte Autoguard BC IV Catheter Recalled for Tubing Defect and Leakage
Becton Dickinson has recalled certain BD Insyte Autoguard BC IV catheters due to potential holes in the catheter tubing that could cause leakage during insertion. The recall involves 26,400 units distributed in the United States.
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: FDA Class II recall of a medical device with a structural defect (hole in catheter tubing) that creates risk of leakage during insertion. This qualifies as a risk-of-harm product, though no illnesses or injuries have been reported.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling BD Insyte Autoguard BC Shielded IV Catheters (REF 382533, 20 GA x 1.00 in) due to a manufacturing defect. Some catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
The affected product is intended for short-term peripheral vascular access to sample blood, monitor blood pressure, or administer fluids. The recall involves 26,400 units distributed in Illinois. The affected lot is 4127714.
Healthcare providers and patients using this product should discontinue use and contact Becton Dickinson for replacement or return instructions. Patients who have received this catheter should consult with their healthcare provider if they have any concerns about their condition.
The recalled product
- Product
- BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to…
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- Category
- Medical Device — IV Catheter
- Affected units
- 26,400
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 # 4127714/ UDI-DI: 00382903825332
Distribution
Distributed in 1 state:
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