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SAFE-T-FILL Micro Capillary Blood Collection, 200 L recallZ-0547-2026 · ASP Global, LLC. dba Anatomy Supply Partners, LLC. · initiated Sep 26, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ASP Global, LLC. dba Anatomy Supply Partners, LLC. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process change control

What the company is doing

On 09/26-29/2025, ASP Global emailed an URGENT MEDICAL DEVICE RECALL Letter to customers. ASP Global, LLC, is voluntarily recalling all RAM Scientific SAFE-T-FILL products within remaining expiry. ASP Global was made aware that our contract manufacturer for the RAM Scientific SAFE-T-FILL products was issued an FDA Warning Letter citing significant violations of the Quality System requirements, including inadequate production and process controls, as well as design controls. Customers are instructed to: a) Discontinue use of the recalled products immediately. b) Quarantine any remaining inventory to prevent further use. c) If critical or abnormal test results were obtained using the affected SAFE-T-FILL products, ensure they are verified through repeat or confirmatory testing in accordance with institutional protocols (e.g., venous confirmation of abnormal pediatric screening results). d) Dispose remaining inventory in accordance with your local facility guidelines or notify ASP Global at [email protected] for return authorization and disposal. e) Complete and return the Recall Response Form to confirm receipt and actions to [email protected]. For questions or assistance - contact [email protected] (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM ET

Recall details

Recall number
Z-0547-2026
Status
Open, Classified
Initiated by the company
Sep 26, 2025
Posted by the FDA
Nov 19, 2025
Recalling firm
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Quantity
27950
Product code
JKA
FDA submissions
K983517
Distribution
Distribution US nationwide and Canada.

Product description

SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Code information (models, lots, serial numbers)

Model Number: 07 7150 GTIN (Inner Pack): 30643351000162 UDI-DI: 10643351000168 All Lots produced from 01AUG2023 to 28FEB2025: 23I4024, 24B4196, 24H4129, 24J4135, 24J4345, 25B4104

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97592).

Sources and updates

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