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: 49000 Lot/code info: Model Number: 07 7220 GTIN (Inner Pack): 30643351000094 UDI-DI: 10643351000090 All Lots produced from 01AUG2023 to 28FEB2025: 23H4114, 23I4054, 23J4036, 24A4107, 24H4123, 24I4324, 24L4007
30643351000094, 10643351000090
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.