C.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
C.R. Bard is recalling SureStep Intermittent Catheter Trays because complaints indicated contamination on the surface of the included Pericare wipes.
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 is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard Inc. is recalling SureStep Intermittent Catheter Trays and Preamendment trays that contain Pericare wipes. The recall was initiated due to complaints indicating the presence of contamination on the surface of these wipes. The affected products are intended for urological use in the drainage, collection, or measurement of urine.
Approximately 391,720 units and kits were distributed worldwide, including nationwide in the United States and in Bahrain, Canada, Costa Rica, Guatemala, Mexico, Saudi Arabia, and the United Arab Emirates. The source text does not specify the exact nature of the contamination or report any illnesses or injuries associated with the product.
Consumers should stop using the affected trays and contact C.R. Bard Inc. for further instructions. The recall covers specific lot numbers and UDI codes listed in the official FDA notice.
The recalled product
- Product
- Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741183218¿ 10801741183215 00801741183232 10801741183239 00801741183225¿…
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Catheter Trays
- Hazard
- Affected units
- 391,720
Distribution
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