FDA Device recall Z-0561-2026
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L by Asp Global, citing due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0561-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-26 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Asp Global |
| Distribution | US |
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Identifiers
| code_info | Model Number: 06 0007 GTIN (Inner Pack): 30643351000308 UDI-DI: 10643351000304 All Lots produced from 31JUL2023 to 2…Model Number: 06 0007 GTIN (Inner Pack): 30643351000308 UDI-DI: 10643351000304 All Lots produced from 31JUL2023 to 28FEB2025: 23I4008, 24D4024, 24D4155, 24E4126, 24E4127, 24E4287 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0561-2026%22
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