Bard Medical Recalls SureStep Foley Tray System Due to Leakage Risk
Bard Medical Division is recalling SureStep Foley Tray Systems because urine may leak around the vent on the vented sample port.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential leak in a medical device, which is a moderate risk but does not meet the criteria for severe injury or death.
Plain-English summary
Bard Medical Division is recalling the SureStep(TM) FOLEY TRAY SYSTEM, a preconnected closed system foley tray. The recall involves 883,171 units distributed in the US, Canada, and the UAE.
The recall was initiated due to a potential for urine leakage around the vent on the vented sample port. This defect could compromise the integrity of the closed system.
Healthcare facilities and consumers should stop using the affected product codes and lot numbers listed in the official recall notice. Users should contact Bard Medical Division for instructions on returning or replacing the devices.
The recalled product
- Product
- SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914…
- Manufacturer
- Bard Medical Division
- Hazard
- Affected units
- 883,171
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)
- Product Code
- Lot Numbers A119214M
- Lot numbers: NGCV3931
- NGCV0249 A119216M
- Lot numbers: NGCU1498
- NGCT3665
- NGCU3726
- NGCV0228
- NGCV1406
- NGCS2897
- NGCV2240
- NGCV3113
- NGCV4031
- NGCV3929
- NGCW2317
- NGCW1354 A119218M
- Lot numbers: NGCW0723 A119416M
- Lot numbers: NGCT2589
- NGCT3587
- NGCT4393
Distribution
Distribution scope not specified by the agency.
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