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: 209000 Lot/code info: Model Number: 06 0508 GTIN : 30643351000384 UDI-DI: 10643351000380 All Lots produced from 1AUG2020 to 28FEB2025: 21F4062, 21L4388, 22G4487, 23C4341, 23F4164, 23G4172, 23G4210, 24I4053, 24I4327, 24I4330, 24I4331, 24I4409, 24J4141, 24J4350
30643351000384, 10643351000380
Official record: FDA (Device enforcement) ↗
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