FDA-Device2026-07-08Class IIPROCESSING DEFECT
Medline Arterial Line and IV Securement Kits recalled for Lidocaine quality issues
What this means
Medline Industries is recalling two medical convenience kits that contain Lidocaine Ampules from Huons Co., Ltd. The Lidocaine was flagged for quality issues during an FDA inspection of the manufacturer's facility. About 250 kits were distributed nationwide.
- Check if you have Medline Arterial Line Kit (Model ART890B, Lot 2025102390) or Ultrasound Guided IV Securement Set (Model IVS3350, Lot 2025102490)
- Do not use affected kits
- Contact Medline for instructions on return or disposal
- Report any use of affected kits to Medline or FDA MedWatch
The agency's original wording
Hazard
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
250 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2026More Medline recalls
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- FDA-Device2026-09-30Medline convenience kits recalled for sharp brush edges in Healthmark channel brushes
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