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: 50050 Lot/code info: Model Number: 07 7120 GTIN (Inner Pack): 30643351000087 UDI-DI: 10643351000144 All Lots produced from 01AUG2023 to 28FEB2025: 24H4127, 24I4326, 24J4134, 24J4344, 24K4370, 24L4005, 25B4103
30643351000087, 10643351000144
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.