There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Reason for recall: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. Distribution: US Nationwide distribution. Quantity: 182,344 total units Lot/code info: 5400-222-208S UDI-DI: 07613327500486, Lot Numbers: 2024020221 2024051720 2024082321
07613327500486
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.