BD Insyte Autoguard BC Winged IV Catheter Needle Retraction Issue
Becton Dickinson is recalling a specific lot of BD Insyte Autoguard BC Winged IV catheters (REF 382633, Lot 4222721) due to reports that the catheter needle may be slow to retract or fail to retract entirely.
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 medical device recall involving a safety mechanism failure (needle retraction) that creates a risk of needlestick injury. Although no illnesses or injuries are explicitly reported in the source, the hazard poses a direct and significant risk to healthcare workers and patients, placing it in the High category under the rubric for risk-of-harm medical devices.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling REF 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm), from Lot 4222721 (UDI: 382903826339). The recall affects 50 units distributed worldwide, including US nationwide distribution across multiple states, as well as Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam.
The catheter is being recalled due to customer complaints indicating the possibility that the catheter needle may be slow to retract or fail to retract. A needle that does not retract properly poses a risk of needlestick injury or other complications during use.
Healthcare facilities and individuals in possession of this product should discontinue use and contact Becton Dickinson for further instructions regarding the affected lot.
The recalled product
- Product
- REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- Hazard
- needlestick-risk
- device-malfunction
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: 4222721/ UDI: 382903826339
Distribution
Distributed nationwide across the United States.
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