Busse Hospital Disposables
75 ARKAY DR., HAUPPAUGE, NY, US
Registered product codes
78 product codes
Recent MDR events
25 on file
- BUSSE HOSPITAL DISPOSABLESMar 13, 2026Malfunction2433012-2026-00001
- BONE MARROW BIOPSY / ASPIRATION TRAY W/ BIOPSY & ASPIRATION NEEDLE / STERILE / LMay 20, 2025Malfunction2433012-2025-00002
- I STYLE ASPIRATION NEEDLEApr 16, 2025MalfunctionMW5169163
- PEDIATRIC LUMBAR PUNCTURE TRAYApr 14, 2025Malfunction2433012-2025-00001
- BUSSE HOSPITAL DISPOSABLESDec 22, 2023Injury2433012-2023-00001
- BUSSE HOSPITAL DISPOSABLESOct 20, 2022Malfunction2433012-2022-00003
- BUSSE HOSPITAL DISPOSABLESSep 15, 2022Malfunction2433012-2022-00002
- BUSSE BONE MARROW BIOPSY/ASPIRATION TRAY J STYLE BIOPSY NEEDLEAug 3, 2022MalfunctionMW5111258
- BUSSE HOSPITAL DISPOSABLESMar 15, 2022Malfunction2433012-2022-00001
- CURETTE, UTERINEFeb 16, 2022Malfunction13541263
Recalls
76 on file
- Open, ClassifiedJan 3, 2024
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
View FDA record ↗ - Open, ClassifiedJan 3, 2024
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
View FDA record ↗ - Open, ClassifiedJan 3, 2024
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
View FDA record ↗ - Open, ClassifiedNov 29, 2022
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
View FDA record ↗ - Open, ClassifiedNov 29, 2022
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
View FDA record ↗ - TerminatedJul 20, 2004
Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
View FDA record ↗ - TerminatedJul 20, 2004
Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
View FDA record ↗ - TerminatedJul 20, 2004
Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
View FDA record ↗ - TerminatedUnknown
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
View FDA record ↗ - TerminatedUnknown
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
View FDA record ↗
Compliance history
Matched by FEI 2433012.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.