C.R. Bard Foley Catheter Trays Recalled for Sterile Packaging Defects
C.R. Bard is recalling 3,980 units of Foley catheter supply kits due to potential packaging defects that may compromise the sterile barrier. No illnesses have been reported.
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 a risk-of-harm medical device recall where no injuries have been reported. Foley catheters are inserted into the body, and a compromised sterile barrier creates substantial risk of urinary tract infection and related complications. The Class II classification and absence of reported incidents prevent a higher score.
Plain-English summary
C.R. Bard Inc. is recalling 3,980 units of Foley catheter supply kits (Catalog A399400A) due to potential packaging defects that may compromise the sterile barrier of the products.
The affected units include SureStep Foley Trays, Add-a-Foley Complete Care Drainage Bags, and StatLock Stabilization Devices from Lots NGFR3569 and NGFR2691 (both with an expiration date of December 28, 2020). These products were distributed nationwide across the United States.
A compromised sterile barrier could allow non-sterile contamination of medical devices that are intended for placement inside the patient's urinary system, potentially resulting in infection. The company has not received reports of illnesses or injuries related to this issue as of the recall announcement.
Users of affected products should contact C.R. Bard Inc. for instructions on how to proceed, including whether to replace the affected units.
The recalled product
- Product
- Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Hazard
- packaging-defect
- sterile-barrier-compromise
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 A399400A
- Lot NGFR3569
- UDI (01)00801741073915(17)201228(10)
- Lot NGFR2691
- UDI (01)00801741073915(17)201228(10) Expanded 10/8/2021 adding Lot NGFR2691
Distribution
Distributed nationwide across the United States.
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