Theragenics Brachytherapy Applicator Needles Recalled for Unsealed Pouches
Theragenics is recalling Brachytherapy Applicator Needles because some pouches were not sealed, potentially compromising sterility.
What this means for you
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 unsealed packaging poses a risk of contamination or loss of sterility for a medical device used in brachytherapy, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Theragenics Corporation is recalling Brachytherapy Applicator Needles (18g x 20cm) because some of the pouches containing the needles were not sealed. The device consists of a wire stylus with a plastic handle, a plastic needle hub, a protective needle sleeve, and a hollow steel needle.
The recall involves 480 packs (5 needles each), which are part of a box of 25 needles containing five single packs and four 5-packs. The affected lot number is 180904-80. The product was distributed nationwide to Florida, California, Alabama, Delaware, North Carolina, Texas, Utah, and Mississippi, as well as internationally to South Africa.
Healthcare providers and consumers should stop using the affected needles and contact Theragenics Corporation for further instructions or a replacement.
The recalled product
- Product
- Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
- Manufacturer
- Theragenics Corporation
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 (4)
- Box part number CPPS-MN-1820
- Multipack part number CPPS-MN-1820-5
- UDI: (01)00813787021515(10)18090480(11)180904(17)220831
- Lot # 180904-80
Distribution
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