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FDA (Device enforcement)Recalled 2025-09-26class ii

ASP Global, LLC. dba Anatomy Supply Partners, LLC.: SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic cap

Hazard

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Details from the source

Reason for recall: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. Distribution: Distribution US nationwide and Canada. Quantity: 620502 Lot/code info: Model Number: 06 0402 GTIN (Inner Pack): 30643351000346 UDI-DI: 10643351000342 All Lots produced from 01AUG2020 to 28FEB2025: 22A4541, 22G4485, 22K4018, 23A4160, 23C4340, 23F4168, 23F4169, 23H4107, 23I4055, 23J4039, 24E4129, 24F4189

UPC codes

30643351000346, 10643351000342

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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