Home / Recalls / Busse Hospital Disposables, Inc. / Z-0593-2024

Z-0593-2024 Class I Ongoing

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

Recall Details

Product Type
Devices
Report Date
January 10, 2024
Initiation Date
November 30, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
536

Product Description

Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

Reason for Recall

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 Pattern

US Nationwide distribution.

Code Information

UDI-DI 00849233010727 Lots 2210077 2210112 2310275 2310331

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-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-1160-2022 Class II — Nerve Block Tray Catalog Number: 9342 (February 22, 2022)
  • Z-1196-2022 Class II — Pellet Insertion Tray Catalog Number: B1654 (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)
  • Z-1159-2022 Class II — Single Shot Epidural Tray Catalog Number: 8417 (February 22, 2022)
  • Z-1203-2022 Class II — 3.2MM Pellet Insertion Tray Catalog Number: B9743 (February 22, 2022)