C.R. Bard Recalls Medical Devices Containing Latex Catheters
C.R. Bard is recalling specific medical device trays and stabilization devices because they contained latex catheters instead of silicone catheters.
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 3/5 (High).
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: The recall involves a material substitution (latex instead of silicone) which poses a risk of allergic reaction or harm, but the source text does not report any illnesses or injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard, Inc. is recalling 2,690 units of SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, and Temperature STATLOCK Stabilization Device. The recall was initiated because the products contained a latex catheter instead of the intended silicone catheter.
The affected units were distributed in the United States to the states of California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Nebraska, Nevada, New Jersey, New Mexico, New York, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. The specific code for the affected units is NGAQ4149.
Consumers and healthcare facilities should stop using the affected products and contact C.R. Bard, Inc. for further instructions or a replacement.
The recalled product
- Product
- SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 2,690
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)
- NGAQ4149
Distribution
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