A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
Reason for recall: A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025. Distribution: Domestic distribution nationwide. No foreign distribution. Quantity: 835 cases total (6 units/case) Lot/code info: UDI-DI 00650862110012 Lots 492065 and 492075
00650862110012
Official record: FDA (Device enforcement) ↗
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