Bard BrachySource Iodine-125 Radioactive Seeds Recalled for Dosage Mix-Up
Bard Brachytherapy is recalling Iodine-125 radioactive seeds because incorrect dosage levels were mixed up and sent to two hospitals in California and Georgia.
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 high-risk medical device where incorrect dosage levels were distributed, creating a risk of harm through improper radiation treatment, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bard Medical Division is recalling BARD BrachySource Iodine-125 Radioactive Seeds in Mick Applicators and loose seeds in vials with sterile spacers. The recall involves specific lots of 0.28 mCi and 0.36 mCi seeds distributed to the states of California and Georgia.
The recall was initiated because incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. One hospital ordered 0.36 mCi seeds but received 0.28 mCi seeds, while the other hospital experienced the reverse mix-up.
Hospitals and medical facilities that received these products should contact Bard Brachytherapy, Inc. for instructions on how to return the affected seeds.
The recalled product
- Product
- BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the…
- Manufacturer
- Bard Brachytherapy, Inc.
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)
- Product Code:1251CSR
Distribution
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