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IV Start Kit

ITL ASIA PACIFIC SDN. BHD. · Model IVSK100 · UDI-DI 09555240405210

LRS Prescription
10
510(k) clearances
361
Adverse events
165
Recalls
67
Facilities

Description

IV Start Kit is a single-use, disposable procedure packs with various combination of components, such as adhesive dressing, underpad, gauze, label, tourniquet, and sterile field. The procedure packs are widely used by clinical professionals using aseptic technique for patient requires Intravenous Cannula Insertion.

Recalls

DateFirmReason
2026-08-11Medline Industries, LPThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu
2026-07-20Medline Industries, LPDownstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the ap
2026-06-12Medline Industries, LPThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi
2026-05-21Medline Industries, LPThe 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 qu
2026-04-27Medline Industries, LPKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-03-16Medline Industries, LPMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web
2026-03-11ARROW INTERNATIONAL, LLCDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.