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ASP Global, LLC. dba Anatomy Supply Partners, LLC.: SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004

Medical DevicesSource: FDA (device) · Date: 2025-11-26

Read the official notice at FDA (device) →

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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 Collection Tube Extender, Model 09 1004
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: 09 1004 GTIN (Inner Pack): 30643351000223 UDI-DI: 10643351000229 All Lots produced from 01AUG2020 to 28FEB2025: 21D4585, 22E4059, 22J4037, 23I4016, 23J4029
Product quantity
27100
Voluntary mandated
Voluntary: Firm initiated
City
Austell
State
GA
Country
United States
Event id
97592
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