C.R. Bard SureStep Foley Catheter Tray Sterile Barrier Defect Recall
C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.
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 medical device recall involving potential sterile barrier defects on a critical medical device (Foley catheter tray). Although no illnesses or injuries are reported in the source text and the hazard is stated as potential rather than confirmed, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
C.R. Bard Inc. is recalling 5,950 SureStep Foley Tray kits (catalog A319416AM) distributed nationwide. The product includes integrated components: Bardex I.C., Complete Care, Urine Meter, Temperature Sensing, and StatLock Stabilization Device. Affected lot numbers are NGEVX107 (expiring 08/31/2022), NGFR3116 (expiring 02/28/2023), and NGFS1808 (expiring 02/28/2023).
The recall was initiated due to potential packaging defects that may impact the product's sterile barrier. The FDA has classified this as a Class II recall.
Healthcare facilities and medical providers across the United States who have received affected units should be aware of this recall.
The recalled product
- Product
- Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Hazard
- packaging-defect
- sterile-barrier-defect
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 (5)
- Catalog A319416AM
- Lots NGEVX107 (exp. 08/31/2022)
- UDI (01)00801741073861(17)201220(10)
- NGFR3116 (exp. 02/28/2023)
- and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(10)
Distribution
Distributed nationwide across the United States.
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