CLASS II Device recall · Reported 2 Nov 2016 · FDA Enforcement Report
Neptune Plus (Hemostatic Pad), Part Numbers recalled by TZ Medical
TZ Medical is recalling Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the, distributed nationwide in the US. The recall was initiated on 7 Jul 2016 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-0298-2017
- FDA event ID
- 74809
- Recalling firm
- TZ Medical, Portland, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2016
- FDA classified
- 21 Oct 2016
- Reported
- 2 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 7 Jul 2016 | Recall initiated by company | |
| 21 Oct 2016 | Classified by FDA | +106 days |
| 2 Nov 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.
Product as listed by the FDA
Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy
Where it was distributed
Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.
Nationwide AlabamaCaliforniaFloridaGeorgiaIllinoisIndianaKentuckyMissouriMississippiNorth CarolinaNevadaNew YorkPennsylvaniaSouth CarolinaTennesseeTexasWest Virginia
Questions about this recall
Is Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the recalled?
Yes. TZ Medical recalled Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the on 7 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-0298-2017.
Why was it recalled?
Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.
Which lots are affected?
Lot R970249
Where was it sold?
Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.
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.
More recalls from TZ Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neptune Plus, Hemostasis Pad With Antimicrobial Barrier recalled | TZ Medical | Device Malfunction | Nationwide |
| Device | CLASS II | SilverStat, sterile 2" x 2 " calcium alginate hemostasis recalled | TZ Medical | Sterility | 18 states |
| Device | CLASS II | adult defibrillation, cardioversion, pacing recalled by TZ Medical | TZ Medical | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |