Class II U.S. Food and Drug Administration

Anatomy Supply Partners, LLC. AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L recall: Due to products manufactured under an inadequate quality system to include

Recall published 11 months ago

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

The hazard

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

Recall details

Recall number
Z-0549-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Anatomy Supply Partners, LLC.
Product type
Medical devices
Units affected
49000
Distribution
Nationwide
Made in
United States
Lot / code info
Model Number: 07 7220 GTIN (Inner Pack): 30643351000094 UDI-DI: 10643351000090 All Lots produced from 01AUG2023 to 28FEB2025: 23H4114, 23I4054, 23J4036, 24A4107, 24H4123, 24I4324, 24L4007

Products covered by this recall

AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

What this device recall means for you

Most device recalls are corrections rather than removals: the product stays in use and the manufacturer issues updated instructions, a software patch or a replacement part. Check which applies before you change anything.

  1. Match the model, catalogue and lot numbers above against the label on your device or its packaging.
  2. If the device is implanted or you depend on it daily, do not remove, disable or stop using it before speaking to your clinician. The notice above explains the specific failure mode they need to know about.
  3. If you are a clinician or facility, quarantine affected stock, check whether the manufacturer has issued a field correction, and work through your usual recall log.
  4. Home users should contact the supplier who provided the device — a hospital, DME company or online retailer — as they hold the serial-number records needed to action the recall.
  5. Problems with a device can be reported to the FDA through MedWatch, which feeds the same enforcement database this page is built from.

Replacements, repairs and reimbursement

Device remedies are handled through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number shown on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free of charge by the manufacturer, who pays return shipping.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not be charged a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim will rest on.

Company contact: ASP Global, LLC. dba Anatomy Supply Partners, LLC. — 7800 Third Flag Pkwy, Austell, GA, 30168-7657

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

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