CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
Mixing Fleas for Safe-t-fill Blood Gas Capillaries recalled
ASP Global is recalling Mixing Fleas for Safe-t-fill Blood Gas Capillaries, distributed nationwide in the US. The recall was initiated on 26 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0566-2026
- FDA event ID
- 97592
- Recalling firm
- ASP Global, Austell, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2025
- FDA classified
- 19 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Sep 2025 | Recall initiated by company | |
| 19 Nov 2025 | Classified by FDA | +54 days |
| 26 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Product as listed by the FDA
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Where it was distributed
Distribution US nationwide and Canada.
Questions about this recall
Why was it recalled?
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Which lots are affected?
Model Number: 07 9503 GTIN (Inner Pack): 30643351000360 UDI-DI: 10643351000366 All Lots produced from 01FEB2023 to 28FEB2025: 22B4465, 22E4465, 22I4072, 23B4158, 23C4345, 23F4176, 23H4109, 23I4060, 24D4021, 24E4130, 24E4131
Where was it sold?
Distribution US nationwide and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
23 other products · FDA event 97592This product is part of a recall event; the main page for the event is A clear, plastic capillary blood collection tube recalled by ASP Global.
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