Sensica Urine Output System recalled for measurement accuracy complaints
C.R. Bard is recalling 457 Sensica Urine Output System units nationwide due to complaints about urine output measurement accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Medical device with documented measurement accuracy defects constitutes a risk-of-harm product where injury has not yet been reported, placing it in the High severity category despite the Class II classification and absence of reported illnesses.
Plain-English summary
C.R. Bard Inc is recalling the Sensica Urine Output System due to complaints relating to urine output measurement accuracy. The recall affects 457 units distributed nationwide in the United States.
The affected devices are identified by catalog number SCCS1002 and SCCS1002E with various lot numbers. This is an FDA Class II recall, with additional information available through FDA recall number Z-1293-2022.
The recalled product
- Product
- Sensica Urine Output System
- Manufacturer
- C.R. Bard Inc
- Hazard
- Affected units
- 457
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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