C.R. Bard Recalls SureStep Foley Tray Systems Due to Residue
C.R. Bard is recalling 8,392 SureStep Foley Tray Systems because a white paper-type residue may be attached to the catheter.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential foreign residue on a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
C.R. Bard Inc is recalling 8,392 units of the SureStep Foley Tray System. The product is intended for the drainage, collection, or measurement of urine, typically via catheter insertion through the urethra or other placement methods.
The recall was initiated because there is a potential for a white paper-type residue to be attached to the catheter. The affected units are identified by Catalog Number A304716A and UDI 00801741104299. Specific lot numbers include NGDX4745, NGDY0567, NGDW1548, NGDW0234, NGDX4088, NGDX4704, and NGDY0568, with expiration dates ranging from November 30, 2021, to March 20, 2021.
The affected products were distributed nationwide in the United States, including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, and WV. Healthcare providers and facilities should stop using the affected units and contact C.R. Bard for further instructions.
The recalled product
- Product
- SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by…
- Manufacturer
- C.R. Bard Inc
- Hazard
- Affected units
- 8,392
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 (6)
- NGDY0567 (Exp. 03/20/2021)
- NGDW1548 (Exp. 11/30/2021)
- NGDW0234 (Exp. 11/30/2021)
- NGDX4088 (Exp. 11/30/2021)
- NGDX4704 (Exp. 11/30/2021)
- NGDY0568 (Exp. 11/30/2021)
Distribution
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