Hauppauge, NY, United States
Busse Hospital Disposables, Inc. recalls
3 recalls recorded since 2018, most recently on 30 November 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 30 November 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0594-2024, Z-0593-2024, Z-0592-2024
- Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
- Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
- Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Ongoing Class II Medical devices
- Recall started
- 21 October 2022
- Reason
- 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
- Distribution
- TX
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0325-2023, Z-0326-2023
- Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
- Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Terminated Class II Medical devices
- Recall started
- 22 February 2022
- Terminated
- 17 April 2024
- Reason
- 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
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1203-2022, Z-1194-2022, Z-1158-2022, Z-1159-2022, Z-1193-2022, Z-1200-2022, Z-1164-2022, Z-1176-2022, Z-1192-2022, Z-1178-2022, Z-1173-2022, Z-1175-2022 and 46 more
- 3.2MM Pellet Insertion Tray Catalog Number: B9743
- Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
- Nerve Block Tray Catalog Number: 8415
- Single Shot Epidural Tray Catalog Number: 8417
- SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
- SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
- Pain Tray Catalog Number: 9883
- Core Biopsy Tray Catalog Number: 8673R4
- and 50 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.