C.R. Bard Recalls 86 Non-Sterile Bard Dimension Stone Baskets
C.R. Bard is recalling 86 non-sterile Bard Dimension Stone Baskets due to a Class II recall classification.
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. Per the rubric, Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of temporary or medically reversible harm.
Plain-English summary
C.R. Bard, Inc. is recalling 86 units of the Bard Dimension Stone Basket. The product is a teardrop-shaped medical device intended for the endoscopic removal of renal and ureteral stones. The device consists of a handle, shaft, and basket.
The recall is classified as Class II by the U.S. Food and Drug Administration. The source text notes that the product is non-sterile. The specific reason for the recall is not detailed in the provided text beyond the non-sterile status and agency classification.
The affected units were distributed worldwide, including in the United States states of AL, FL, NJ, NY, NC, PA, SC, TX, and WI, as well as in Germany, Italy, Kuwait, and Luxembourg. The specific product code is 042316 and the lot number is BMXJM031.
The recalled product
- Product
- Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle…
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Urological
- Hazard
- Affected units
- 86
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 (2)
- Product code: 042316
- Lot number: BMXJM031
Distribution
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