Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Reason for recall: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Distribution: Distribution US nationwide and Canada. Quantity: 103200 Lot/code info: Model Number: 07 7250 GTIN (Inner Pack): 30643351000117 UDI-DI: 10643351000113 All Lots produced from 01AUG2023 to 28FEB2025: 23H4115, 23I4023, 23J4037, 24B4193, 24D4019, 24H4124, 24I4325, 24J4238, 24L4006, 25B4101
30643351000117, 10643351000113
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.