BD Insyte Autoguard Shielded IV Catheter needle retraction defect
Becton Dickinson is recalling one lot of BD Insyte Autoguard Shielded IV Catheters (REF 381433, 20GA x 1.00 in) due to reports that the catheter needle may retract slowly 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 involving a risk-of-harm medical device (needle retraction failure in an IV catheter presents a potential for needlestick injury). The source text does not report any illnesses or injuries, but the hazard is inherent to the product defect, not merely theoretical.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling Lot #4290664 of the BD Insyte Autoguard Shielded IV Catheter (REF 381433, 20GA x 1.00 in, 1.1x25 mm, 65 mL/min, STERILE, Rx Only). According to customer complaints, the catheter needle may be slow to retract or fail to retract.
The recalled product was distributed worldwide, including across the United States and to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam. A total of 50 units were affected.
If you have this product in use or in stock, contact Becton Dickinson Infusion Therapy Systems, Inc. for instructions on how to proceed. Healthcare providers should review their inventory for the affected lot number (4290664/UDI: 382903814336) and follow the manufacturer's guidance.
The recalled product
- Product
- REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 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 # 4290664/UDI:382903814336
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.
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