Recall Z-1293-2022
C.R. Bard Inc · initiated May 19, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sensica Urine Output System
Codes / lots: UDI: (01) 0 0801741215773; Catalog Number: SCCS1002 (Lot Numbers: BMFURMSF03, BMFURMSF07, BMFURMSF08, BMFURMSF10, BMFURMSF12, BMFURMSF13, BMFURMSF15, BMFURMSF16, BMFURMSF18, BMFURMSF19, BMFURMSF20, BMFURMSF22, BMFURMSF23, BMFURMSF24, BMFURMSF25, BMFURMSF26, BMFURMSF27, BMFURMSF28, BMFURMSF29, BMFURMSF30, BMFURMSF31, BMFURMSF32, BMFURMSF33, BMFURMSF34, BMFURMSF35, BMFURMSF36, BMFURMSF37, BMFURMSF38, BMFURMSF39, BMFURMSF40, BMFURMSF41, BMFURMSF42, BMFURMSF43, BMFURMSF44, BMFURMSF45, BMFURMSF46, BMFURMSF47, BMFURMSF48, BMFURMSF49, BMFURMSF50, BMFURMSF51, BMFURMSF52, BMFURMSF53, BMFURMSF54, BMFURMSF55, BMFURMSF56, BMFURMSF57, BMFURMSF58, BMFURMSF59, BMFURMSF60, BMFVRMSQ82, BMFVRMSQ84, BMFVRMSQ85, BMFVRMSQ86, BMFVRMSQ87, BMFVRMSQ88, BMFVRMSQ92, BMFVRMSQ94, BMFVRMSQ95, BMFVRMSQ96, BMFVRMSQ97, BMFVRMSQ98, BMFVRMSQ99, BMFVRMSR00, BMFVRMSR01, BMFVRMSR02, BMFVRMSR05, BMFVRMSR06, BMFVRMSR07, BMFVRMSR08, BMFVRMSR09, BMFVRMSR10, BMFVRMSR11, BMFVRMSR12, BMFVRMSR13, BMFVRMSR14, BMFVRMSR15, BMFVRMSR19, BMFVRMSR20, BMFVRMSR22, BMFVRMSR23, BMFVRMSR24, BMFVRMSR25, BMFVRMSR26, BMFVRMSR27, BMFVRMSR28, BMFVRMSR29, BMFVRMSR31, BMFVRMSR34, BMFVRMSR36, BMFVRMSR37, BMFVRMSR38, BMFVRMSR39, BMFVRMSR40…
Reason for recall
Complaints relating to urine output measurement accuracy.
FDA-determined cause: Under Investigation by firm
Action taken
The firm issued a recall notification via email and Fed Ex on 05/19/2022. The letter instructs the consignee to immediately discontinue use of the system, quarantine and store to prevent usage, share the notice with users of the product, and return the response form.
Details
- Recall number
- Z-1293-2022
- Initiated
- May 19, 2022
- Product code
- EXS – Urinometer, Electrical
- Quantity
- 457 units
- Distribution
- US Nationwide.
- Recalling firm
- C.R. Bard Inc, Covington, GA