SRI Surgical Recalls Disposable Accessory Packs Due to Labeling Error
SRI Surgical is recalling 802,135 disposable accessory packs distributed nationwide because they did not meet specifications due to a labeling error.
What this means for you
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, which typically corresponds to a moderate severity. The specific defect is a labeling error, which is a minor issue compared to functional defects or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
SRI Surgical is recalling 802,135 units of various Disposable Accessory Packs, also known as convenience kits and custom procedure trays. These products are assemblies of medical devices packaged together according to customer specifications, wrapped in sterilization wrap, and sterilized to allow customers to open one package for a surgical procedure instead of many individual packages.
The recall was initiated because the distribution of the product did not meet specifications, specifically due to a labeling error. The affected units were distributed nationwide, including in the states of California, Florida, Georgia, Kentucky, Maryland, Michigan, North Carolina, New Jersey, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and Utah.
The recall covers a wide range of model numbers, including but not limited to CY1020, GY1250, GY1274, GS1296, and NU1290. Consumers and healthcare facilities should check their inventory for these specific model numbers and stop using the affected products if they match the recalled list.
The recalled product
- Product
- Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a ste
- Manufacturer
- SRI Surgical
- Hazard
- Affected units
- 802,135
Distribution
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