FDA Medical devices recall ·
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L recall
- Recall number
- Z-0553-2026
- Date
- (initiated September 26, 2025)
- Company / brand
- Anatomy Supply Partners
7800 Third Flag Pkwy, Austell, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2100
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 07 7340 GTIN (Inner Pack): 30643351000131 UDI-DI: 10643351000137 All Lots produced from 01AUG2023 to 28FEB2025: 24B4201, 24K4372
Distribution
Distribution US nationwide and Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0553-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.