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Busse Hospital Disposables Recalls
63 recalls on record · June 8, 2022 to January 10, 2024 · Medical Devices
Recalls by year
22
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 10, 2024Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Hazard: 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.
January 10, 2024Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Hazard: 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.
January 10, 2024Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Hazard: 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.
December 7, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Hazard: 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
December 7, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Hazard: 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
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 4.5MM Pellet Insertion Tray Catalog Number: B9807
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls 3.2MM Pellet Insertion Tray Catalog Number: B9743
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls 3.2MM Pellet Insertion Tray Catalog Number: B7345R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Pellet Insertion Tray Catalog Number: B1654
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
June 8, 2022Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Hazard: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products