FDAFDA · Food and drugs·Recall number Z-0427-2024
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Published December 13, 2023 · Recall initiated: August 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Distributor
- Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
- Lot
- UDI-DI (GTIN): 07613327541182. Serial numbers: 2105002838 , 2105002832 , 2202000312 , 2202000286 , 2202000278 , 2202000180 , 2106002241 , 2106001240 , 2107001002 , 2203001053 , 2203001898 , 2112001135 , 2211002054 , 2105002782 , 2210002902 , 2210002890 , 2210002876 , 2210002858 , 2210002848 , 2111001420 , 2206001182
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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