FDA Device recall Z-0545-2026
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿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 Micro Capillary Blood Collection, 200 ¿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-0545-2026 |
| 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 Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Identifiers
| code_info | Model Number: 07 7120 GTIN (Inner Pack): 30643351000087 UDI-DI: 10643351000144 All Lots produced from 01AUG2023 to…Model Number: 07 7120 GTIN (Inner Pack): 30643351000087 UDI-DI: 10643351000144 All Lots produced from 01AUG2023 to 28FEB2025: 24H4127, 24I4326, 24J4134, 24J4344, 24K4370, 24L4005, 25B4103 |
|---|
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-0545-2026%22
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