C.R. Bard Recalls I-125 QuickLink Cartridges Due to Incorrect Quantity
C.R. Bard is recalling I-125 QuickLink Cartridges because the quantity of seeds sent in shipments was incorrect.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a logistical error regarding quantity and activity, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling/shipping errors without reported harm.
Plain-English summary
C.R. Bard, Inc. is recalling I-125 CE Marked QuickLink Cartridges containing Bard Brachysource Radioactive Seeds. The recall involves 134 seeds distributed to Belgium and South Africa. The specific lots affected are BBAY0072, BBAY0079, BBAY0090, BBAY0071, and BBAY0073.
The recall was initiated because the activity and quantity of seeds sent in shipments were incorrect. These medical devices are indicated for the permanent interstitial treatment of selected localized tumors, including head and neck, lung, pancreas, and early-stage prostate cancer.
Healthcare providers and distributors in the affected regions should stop using the recalled products and contact C.R. Bard for further instructions.
The recalled product
- Product
- I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to…
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 134
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)
- Product Code: 1251QCSCE
- Lot No. BBAY0072
- BBAY0079
- BBAY0090
- BBAY0071
- BBAY0073.
Distribution
Distribution scope not specified by the agency.
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