BD Insyte Autoguard Shielded IV Catheter needle retraction failure recall
Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (REF 381423, 22GA X 1.00 IN) due to the possibility that the catheter needle may be slow to retract or fail to retract entirely.
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: This is an FDA Class II medical device recall involving a safety-critical mechanism (needle retraction failure) that poses a risk of needlestick injury or other harm. Although no illnesses or injuries are reported in the source text, the hazard—failure of a protective mechanism on an invasive device—is significant and carries inherent risk of harm.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling BD Insyte Autoguard Shielded IV Catheters (REF: 381423, 22GA X 1.00 IN, 0.9 X 25 MM, 35mL/min). The recalled product has a lot number of 4229661 (UDI: 382903814237) and consists of 50-unit packages.
The recall is due to customer complaints indicating that the catheter needle may be slow to retract or fail to retract. This defect affects the safety mechanism designed to shield the needle after insertion.
The product was distributed worldwide and throughout the United States, including in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. International distribution included Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam.
Consult your healthcare provider or contact Becton Dickinson for guidance on product replacement or further instructions regarding affected IV catheters in use or in stock.
The recalled product
- Product
- REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- 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 # 4229661/UDI: 382903814237
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.
See all 9 products in this recall →Related recalls
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