FDA Medical devices recall ·
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L recall
- Recall number
- Z-0557-2026
- 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
- 397000
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
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: 06 0186 GTIN (Inner Pack): 30643351000278 UDI-DI: 10643351000274 ***All Lots produced from 31JUL2023 to 28FEB2025: 23H4108, 23H4155, 23I4014, 23I4062, 23J4040, 24F4188, 24I4314, 24L4002, 25B4097
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-0557-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.