BD Insyte Autoguard Winged Shielded IV Catheter Needle Retraction Issue
Becton Dickinson is recalling BD Insyte Autoguard Winged Shielded IV Catheters (Lot# 4282308) because the catheter needle may be slow to retract or fail to retract entirely following use.
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 of a medical device with a risk-of-harm mechanism (needle retraction failure could result in needlestick injury or patient harm), and no reported illnesses or injuries are stated in the source text. Per the rubric, a risk-of-harm medical device where injury has not yet been reported scores High (3).
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling the BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm), 35 mL/min, REF 381923, Lot# 4282308. The recall stems from customer complaints indicating that the catheter needle may be slow to retract or fail to retract.
The affected product has been distributed worldwide, including throughout the United States, as well as to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam. Affected patients and healthcare facilities should stop using remaining units from the recalled lot and contact Becton Dickinson for instructions on product replacement or return.
This is a Class II recall. Anyone with questions about this recall or who has used the affected catheter should contact their healthcare provider or Becton Dickinson for guidance.
The recalled product
- Product
- REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- Hazard
- needle-retraction-failure
- needlestick-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# 4282308/UDI: 382903819232
Distribution
Distributed nationwide across the United States.
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