Medline IV Catheter Kits Recalled Due to Needle Retraction Failure
Medline recalls IV catheter convenience kits where the needle is slow to retract or fails to retract during insertion. The affected kits (36 units, Lot 24LDA590) were distributed across six states.
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 a Class II FDA recall for a medical device with a known malfunction (needle slow/fails to retract) that poses risk of needlestick injury. Since no illnesses or injuries have been reported and this is not a Class I recall, this qualifies as a risk-of-harm product without reported injury, per the rubric.
Plain-English summary
Medline Industries, LP is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters (22 GA x 1.00 IN, Ref ACC010665). The affected kits contained 36 units with Lot Number 24LDA590.
The issue was identified during insertion of the catheter: the needle is slow to retract or fails to retract completely. This malfunction poses a risk during healthcare administration, as a needle that does not properly retract could cause needlestick injury.
The kits were distributed nationwide to facilities in Indiana, Kentucky, California, Michigan, Texas, and Washington. The FDA classified this as a Class II recall.
Healthcare providers who have these kits should discontinue use immediately and contact Medline Industries for instructions on returning or replacing the affected product.
The recalled product
- Product
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — IV Catheter
- Hazard
- needle-retraction-failure
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 (3)
- 1) REF ACC010665: UDI/DI 10195327334918 (each)
- 40195327334919 (case)
- Lot Number 24LDA590
Distribution
Distributed nationwide across the United States.
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