Foley Catheter Tray System Recalls Due to Incorrect Material Inserts
SureStep Foley Tray System units contain incorrect inserts labeled incorrectly, risking patient allergic reactions and infections if the wrong material type is used.
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: FDA Class II recall with no reported illnesses or injuries. However, the product involves allergen mislabeling (latex) on a medical device where allergic reaction and infection are potential risks, meeting the High severity criterion for allergen mislabeling on common allergens without reported illness.
Plain-English summary
The SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray (REF: A303316A) is being recalled by C.R. Bard Inc. The tray contains incorrect inserts that do not match the product's labeling.
Specifically, the inserts may be mislabeled in three ways: silicone may be labeled as natural rubber latex, natural rubber latex with infection control coating may be labeled as silicone hydrogel with antimicrobial coating, or natural latex with infection control may be labeled as silicone hydrogel without antimicrobial coating. Users relying on the label to identify the catheter material may select the wrong product type. This mismatch may cause infection and local or systemic allergic reactions, particularly in patients with latex allergies.
Approximately 4,300 units with lot number NGJX6399 were distributed nationwide to healthcare facilities across multiple states.
If you have received this product, contact C.R. Bard Inc or the FDA for instructions on handling affected units. Do not use trays where the insert material does not match the product label.
The recalled product
- Product
- SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
- Manufacturer
- C.R. Bard Inc
- Hazard
- allergen-latex
- mis-labeling
- infection-risk
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 (1)
- Lot#NGJX6399
Distribution
Distributed nationwide across the United States.
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