CLASS II Device recall · Reported 16 Mar 2022 · FDA Enforcement Report
PuraSinus Absorbable Nasal Hemostat, Part Numbers recalled by 3-D Matrix
3-D Matrix is recalling PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006, distributed nationwide in the US. The recall was initiated on 2 Dec 2019 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-0744-2022
- FDA event ID
- 89577
- Recalling firm
- 3-D Matrix, Newton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2019
- FDA classified
- 10 Mar 2022
- Reported
- 16 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Dec 2019 | Recall initiated by company | |
| 10 Mar 2022 | Classified by FDA | +829 days |
| 16 Mar 2022 | 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
The boxes used by the shipper were not validated for use during transport.
Product as listed by the FDA
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Where it was distributed
US Nationwide distribution in the state OH.
Questions about this recall
Is PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 recalled?
Yes. 3-D Matrix recalled PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 on 2 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-0744-2022.
Why was it recalled?
The boxes used by the shipper were not validated for use during transport.
Which lots are affected?
UDI: (01)00860001820829(17)220430(10)19E30A50; Lot Number 19E30A50
Where was it sold?
US Nationwide distribution in the state OH.
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 21 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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