ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Reason for recall: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. Distribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE. Quantity: 57 units Lot/code info: UDI-DI: 00191072200242; Lot: 2405093; Exp: 05/09/2025
00191072200242
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.