Skip to content

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L recallZ-0555-2026 · 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-0555-2026
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
2000
Product code
GIO
Distribution
Distribution US nationwide and Canada.

Product description

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin

Code information (models, lots, serial numbers)

Model Number: 06 0507 GTIN (Inner Pack): 30643351000391 UDI-DI: 10643351000397 All Lots produced from 31JUL2023 to 28FEB2025: 24B4200

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

How recalls are matched to devices · Editorial policy · Report an error on this page