ASP Global, LLC. dba Anatomy Supply Partners, LLC.: SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 0
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ASP Global, LLC. dba Anatomy Supply Partners, LLC.
- Product
- SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
- Reason / hazard
- Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Distribution US nationwide and Canada.
- Recall initiated
- 2025-09-26
- Code info
- Model Number: 07 7221 GTIN (Inner Pack): 30643351000100 UDI-DI: 10643351000106 All Lots produced from 01AUG2023 to 28FEB2025: 24K4083, 24K4371, 25B4100
- Product quantity
- 9150
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Austell
- State
- GA
- Country
- United States
- Event id
- 97592
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