Home / Recalls / Busse Hospital Disposables, Inc. / Z-1189-2022

Z-1189-2022 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
60 units

Product Description

SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1

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: 2110128 2110279 UDI: 00849233004412

Other recalls by Busse Hospital Disposables, Inc.

  • 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-0594-2024 Class I — Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / 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-1204-2022 Class II — SS 4.5MM Pellet Insertion Tray Catalog Number: B9807 (February 22, 2022)
  • Z-1186-2022 Class II — 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362 (February 22, 2022)
  • Z-1162-2022 Class II — Universal Nerve Block Tray Catalog Number: 9818 (February 22, 2022)
  • Z-1200-2022 Class II — SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1 (February 22, 2022)
  • Z-1202-2022 Class II — Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1 (February 22, 2022)