BD Insyte Autoguard Shielded IV Catheter needle retraction malfunction
Becton Dickinson is recalling a specific lot of BD Insyte Autoguard Shielded IV Catheters due to reports that the catheter needle may be slow to retract or fail to retract.
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: The FDA classified this as a Class II recall involving a medical device with a mechanical malfunction (needle retraction failure) that poses a risk of patient injury. Although no illnesses or injuries are reported in the source text, the hazard is real and not merely theoretical, placing this at the High level per the rubric.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling REF 382544 BD Insyte Autoguard Shielded IV Catheters (18 GA x 1.16 in, 95 mL/min) distributed worldwide including across the United States, Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam.
The recall was initiated due to customer complaints regarding a potential defect in which the catheter needle may be slow to retract or fail to retract completely. This defect affects Lot# 4312025 with UDI 00382903825448, comprising 50 units.
Patients and healthcare providers who have received or used this product should contact Becton Dickinson Infusion Therapy Systems, Inc. for further instructions regarding the affected catheters.
The recalled product
- Product
- REF: 382544 BD Insyte Autoguard 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
- puncture-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# 4312025 UDI: 00382903825448
Distribution
Distributed nationwide across the United States.
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