SureStep Foley Tray Recall: Packaging Defects May Compromise Sterile Barrier
C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.
What this means for you
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: This is an FDA Class II recall for a potential sterile barrier defect in a medical device used for urinary drainage. However, the source text reports no actual illnesses, injuries, or deaths. Per the rubric, theoretical hazards to risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616, Lot NGFR3277) distributed nationwide. The recall affects 80 units of this urinary drainage product, which is used for bladder drainage management.
The FDA Class II recall is due to potential packaging defects that may impact the sterile barrier. A compromised sterile barrier could allow contamination of the product.
The affected lot can be identified by catalog number A902616 and lot number NGFR3277 (UDI: 00801741104633). Affected units were distributed nationwide in the United States.
Patients currently using any of the recalled product should discontinue use and contact C.R. Bard Inc or their healthcare provider. Healthcare providers should assess whether patients may have received any of the affected units and take appropriate action.
The recalled product
- Product
- Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
- Manufacturer
- C.R. Bard Inc
- Affected units
- 80
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 (3)
- Catalog A902616
- Lot NGFR3277
- UDI (01)00801741104633(17)251228(10)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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