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Busse Hospital Disposables

ROBERT BUSSE & CO., INC. · Model 1058 · UDI-DI 00849233003231

OGJ Prescription
0
510(k) clearances
74
Adverse events (1 deaths)
45
Recalls
33
Facilities

Description

Single Shot Epidural Tray

Recalls

DateFirmReason
2026-06-17Windstone Medical Packaging, Inc.Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. El
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
2026-04-10Medline Industries, LPMedline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t
2026-03-19Medline Industries, LPDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-03-03MEDLINE INDUSTRIES, LP - NorthfieldThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2024-10-16MEDLINE INDUSTRIES, LP - NorthfieldThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

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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.