Medline IV Catheter Kits Recalled Over Needle Retraction Issue
Medline is recalling 36 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN due to a potential needle retraction failure during insertion.
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 where the needle may fail to retract during insertion, posing a potential needlestick injury risk. No illnesses or injuries have been reported, which limits the score to High per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling specific Medline convenience kits that contain BD Insyte Autoguard Shielded IV Catheters, 22 GA x 1.00 IN, labeled as IV START BOX, REF ACC010665. The recall involves 36 units distributed nationwide in the states of IN, KY, CA, MI, TX, and WA.
The recall was initiated because during insertion of the catheter, the needle may be slow to retract or fail to retract. This defect could pose a risk of needlestick injury to healthcare providers administering the device.
Healthcare providers and facilities that received the affected product should stop using the kits immediately and contact Medline Industries, LP to arrange for return or replacement. The affected units are identified by Lot Number 24LDA590 and UDI/DI codes 10195327334918 (each) and 40195327334919 (case).
Consumers or healthcare providers with questions should contact Medline Industries, LP directly. No illnesses or injuries have been reported in connection with this recall at this time.
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
- Affected units
- 36
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
Part of a larger recall action
This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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