Home / Recalls / Busse Hospital Disposables, Inc. / Z-1164-2022

Z-1164-2022 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
421 units

Product Description

Pain Tray Catalog Number: 9883

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: 2031092 2130020 2130288 2130670 2130020 2130905 2131181 2131317 UDI: 00849233012158

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-1173-2022 Class II — Pump Refill Kit Catalog Number: 7347R1 (February 22, 2022)
  • Z-1195-2022 Class II — Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570 (February 22, 2022)
  • Z-1193-2022 Class II — SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560 (February 22, 2022)
  • Z-1167-2022 Class II — Nerve Block Tray Catalog Number: 3764R2 (February 22, 2022)
  • Z-1165-2022 Class II — Stereo Breast Biopsy Tray Catalog Number: 2383R1 (February 22, 2022)