Busse Hospital Disposables, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 63 (3 Class I)
- 510(k) Clearances
- 35
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0594-2024 | Class I | Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE | November 30, 2023 |
| Z-0593-2024 | Class I | Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE | November 30, 2023 |
| Z-0592-2024 | Class I | Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE | November 30, 2023 |
| Z-0326-2023 | Class II | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 | October 21, 2022 |
| Z-0325-2023 | Class II | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | October 21, 2022 |
| Z-1196-2022 | Class II | Pellet Insertion Tray Catalog Number: B1654 | February 22, 2022 |
| Z-1152-2022 | Class II | Single Shot Epidural Tray Catalog 1292 | February 22, 2022 |
| Z-1160-2022 | Class II | Nerve Block Tray Catalog Number: 9342 | February 22, 2022 |
| Z-1161-2022 | Class II | Universal Nerve Block Tray Catalog Number: 9779 | February 22, 2022 |
| Z-1159-2022 | Class II | Single Shot Epidural Tray Catalog Number: 8417 | February 22, 2022 |
| Z-1194-2022 | Class II | Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568 | February 22, 2022 |
| Z-1198-2022 | Class II | SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1 | February 22, 2022 |
| Z-1185-2022 | Class II | 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360 | February 22, 2022 |
| Z-1166-2022 | Class II | CVC Dressing Change Kit Catalog Number: 2491R1 | February 22, 2022 |
| Z-1175-2022 | Class II | Joint Injection Tray Catalog Number: 8561R1 | February 22, 2022 |
| Z-1183-2022 | Class II | SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354 | February 22, 2022 |
| Z-1176-2022 | Class II | Core Biopsy Tray Catalog Number: 8673R4 | February 22, 2022 |
| Z-1162-2022 | Class II | Universal Nerve Block Tray Catalog Number: 9818 | February 22, 2022 |
| Z-1158-2022 | Class II | Nerve Block Tray Catalog Number: 8415 | February 22, 2022 |
| Z-1151-2022 | Class II | Single Shot Epidural Tray Catalog 1165 | February 22, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141285 | BUSSE EXTENSION SET | February 19, 2015 |
| K120002 | I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE | June 26, 2012 |
| K110883 | J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA | June 8, 2011 |
| K093920 | BUSSE EPIDURAL CATHETER KIT | August 6, 2010 |
| K093909 | BUSSE SURGICAL DRAPES IV | May 6, 2010 |
| K092212 | BUSSE SURGICAL DRAPES III | October 9, 2009 |
| K082297 | BUSSE SURGICAL DRAPE | December 9, 2008 |
| K073222 | MODIFICATION TO:SPECIALTY NEEDLES | April 9, 2008 |
| K070465 | BUSSE EPIDURAL CATHETER | July 19, 2007 |
| K063018 | GLASS LOSS OF RESISTANCE SYRINGE | January 22, 2007 |
| K061394 | SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) | September 6, 2006 |
| K061570 | I-STYLE BONE MARROW ASPIRATION NEEDLE | July 3, 2006 |
| K052843 | BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE | April 17, 2006 |
| K041464 | BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER | November 5, 2004 |
| K032432 | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER | August 28, 2003 |
| K021055 | BUSSE UMBILICAL CORD CLAMP CUTTER | April 29, 2002 |
| K010835 | POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MOD | April 30, 2001 |
| K963260 | DRESSING CHANGE TRAYS | November 22, 1996 |
| K953019 | HYDROPHILIC FOAM DRESSING | September 15, 1995 |
| K952948 | SALINE DRESSING | August 16, 1995 |