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: 78000 Lot/code info: Model Number: 07 6101 GTIN (Inner Pack): 10643351000083 UDI-DI: 10643351000083 All Lots produced from 01AUG2023 to 28FEB2025: 23H4112, 23I4019, 23J4032, 24B4189, 24H4122, 24I4319, 24J4236, 24L4003
10643351000083
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.