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: 352750 Lot/code info: Model Number: 06 0187 GTIN (Inner Pack): 30643351000285 UDI-DI: 10643351000281 All Lots produced from 31JUL2023 to 28FEB2025: 23I4063, 24A4108, 24B4197, 24D4023, 24E4137, 24E4278, 24L4004
30643351000285, 10643351000281
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.