FDANovember 30, 2023device
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
busse hospital disposablesbussebusse hospital
UPCs
00849233011069
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAProduct Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator2024-06-11
- CPSCVPR Brands Recalls Lighters Due to Missing Child Safety Feature, Posing Burn and Fire Hazards; Violation of the Federal Regulation for Cigarette Lighters2024-02-08
- FDAActhar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-12024-02-06
- FDATerlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-012024-02-06
- FDACatalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE2023-11-30
- FDACatalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE2023-11-30
- FDABusse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R12022-10-21
- FDABusse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R12022-10-21
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