Class II U.S. Food and Drug Administration

Anatomy Supply Partners, LLC. Safe-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: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0553-2026
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
2100
Distribution
Nationwide
Made in
United States
Lot / code info
Model Number: 07 7340 GTIN (Inner Pack): 30643351000131 UDI-DI: 10643351000137 All Lots produced from 01AUG2023 to 28FEB2025: 24B4201, 24K4372
UPC codes
30643351000131, 10643351000137

Products covered by this recall

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 30643351000131
  • 10643351000137

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Anatomy Supply Partners, LLC. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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

Questions people ask about this recall

Why was Anatomy Supply Partners, LLC. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 30643351000131, 10643351000137. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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