Recall of 25GA Vitrectomy Cutters Due to Packaging Error
Johnson & Johnson is recalling 392 units of 25GA Vitrectomy Cutters because 20GA cutters may be found in the packaging, posing a surgical risk.
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, and the source text describes a packaging error that could lead to altered surgical technique but does not report any specific injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Johnson & Johnson Surgical Vision Inc. is recalling 392 units of Disposable 25GA Vitrectomy Cutters (REF NGP0025). The recall is due to a packaging error where a 20GA Vitrectomy Cutter may be found inside a package labeled for a 25GA cutter. The affected lot number is 60084881, with a manufacturing date of September 5, 2017, and an expiration date of September 5, 2020.
The use of a vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement. The product is intended for single use to remove vitreous from the eye during a vitrectomy procedure.
The recalled products were distributed in the United States to the states of North Carolina, Nevada, Texas, New York, Utah, Minnesota, Washington, New Jersey, Ohio, and California, as well as internationally to Australia and Japan. Healthcare providers and facilities should check their inventory for this specific lot number and discontinue use of any affected units.
The recalled product
- Product
- Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
- Manufacturer
- Johnson & Johnson Surgical Vision Inc
- Affected units
- 392
Distribution
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