CLASS II Device recall · Reported 24 Mar 2021 · FDA Enforcement Report
Siros D-Vial Prep Set, Product recalled by Sirtex Medical
Sirtex Medical is recalling Siros D-Vial Prep Set, distributed nationwide in the US. The recall was initiated on 22 Feb 2021 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-1275-2021
- FDA event ID
- 87393
- Recalling firm
- Sirtex Medical, North Ryde, New South Wales, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Feb 2021
- FDA classified
- 18 Mar 2021
- Reported
- 24 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 22 Feb 2021 | Recall initiated by company | |
| 18 Mar 2021 | Classified by FDA | +24 days |
| 24 Mar 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential presence of particulate matter in the D-Vial.
Product as listed by the FDA
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
There is a potential presence of particulate matter in the D-Vial.
Which lots are affected?
Lot Numbers: 1031234, 1031225, 1031227, 1031229
Where was it sold?
US Nationwide distribution.
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.
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