Medline Industries, Lp: I.v. Start Kit
Recall Summary Medline Industries is recalling two I.V. start kits (Arterial Line Kit Model ART890B and Ultrasound Guided IV Securement Set Model IVS3350) that contain lidocaine ampules manufactured by Huons Co., Ltd. The lidocaine ampules are being recalled due to quality issues found during an FDA inspection of the manufacturer's facility. These kits were distributed nationwide across all U.S. states and Washington, D.C.
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2d9c14ba-e8f5-47f2-91e1-c069605f6a13