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: 50250 Lot/code info: Model Number: 07 9503 GTIN (Inner Pack): 30643351000360 UDI-DI: 10643351000366 All Lots produced from 01FEB2023 to 28FEB2025: 22B4465, 22E4465, 22I4072, 23B4158, 23C4345, 23F4176, 23H4109, 23I4060, 24D4021, 24E4130, 24E4131
30643351000360, 10643351000366
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.