{"url_path":"/fda/device/recalls/Z-2543-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits:  1) ARTERIAL LINE KIT, Model Number: ART890B;   2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2543-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":113,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2543-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-21\n**Report date:** 2026-07-08\n\n## Product\nMedline Convenience Kits:  1) ARTERIAL LINE KIT, Model Number: ART890B;   2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350\n\n## Reason\nThe 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.\n\n## Affected lots\n1) ART890B, UDI-DI: 10653160360834(each), 00653160360837(case), Lot Number: 2025102390; 2) IVS3350, UDI-DI: 10653160313045(each), 00653160313048(case), Lot Number: 2025102490\n\n## Distribution\nUS Nationwide distribution."}