ASP Global, LLC. dba Anatomy Supply Partners, LLC.: SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, pla
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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 Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
- 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: 06 0186 GTIN (Inner Pack): 30643351000278 UDI-DI: 10643351000274 ***All Lots produced from 31JUL2023 to 28FEB2025: 23H4108, 23H4155, 23I4014, 23I4062, 23J4040, 24F4188, 24I4314, 24L4002, 25B4097
- Product quantity
- 397000
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Austell
- State
- GA
- Country
- United States
- Event id
- 97592
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