Home / Recalls / Busse Hospital Disposables, Inc. / Z-1198-2022

Z-1198-2022 Class II Terminated

Recalled by Busse Hospital Disposables, Inc. — Hauppauge, NY

Recall Details

Product Type
Devices
Report Date
June 8, 2022
Initiation Date
February 22, 2022
Termination Date
April 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
300 units

Product Description

SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1

Reason for Recall

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 Pattern

Nationwide

Code Information

Lot Numbers: 2030982 2031072 2130198 2130352 2130706 2130876 UDI: 00849233002227

Other recalls by Busse Hospital Disposables, Inc.

  • Z-0592-2024 Class I — Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE (November 30, 2023)
  • 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-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-1160-2022 Class II — Nerve Block Tray Catalog Number: 9342 (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-1183-2022 Class II — SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354 (February 22, 2022)