Medline Industries, Lp: Arterial Blood Sampling Kit

Recall Summary Medline Industries is recalling three arterial blood sampling kits nationwide because they contain lidocaine ampules that were made by Huons Co., Ltd. and have quality issues identified during an FDA inspection of the manufacturer's facility. The affected kits are the Arterial Access Tray with Lidocaine (Model ART1145), Universal Central/Arterial Line Insertion Kit (Model ART155A), and Arterial Line Insertion Tray (Model ART1010B).

Recalling firm
Medline Industries, LP
Product
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B
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 I
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/fb769b02-50be-4593-bfa8-34e9a5a9b4ed