CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Wet-Field Hemostatic Eraser Bipolar, fine tip, straight, 5/SP recalled
Beaver-Visitec International is recalling Wet-Field Hemostatic Eraser Bipolar, fine tip, straight, 5/SP, distributed nationwide in the US. The recall was initiated on 26 Feb 2018 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-1801-2018
- FDA event ID
- 79915
- Recalling firm
- Beaver-Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2018
- FDA classified
- 10 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 26 Feb 2018 | Recall initiated by company | |
| 10 May 2018 | Classified by FDA | +73 days |
| 16 May 2018 | 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
Products were packaged with incorrect labeling,
Product as listed by the FDA
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Where it was distributed
US Nationwide and Canada
Questions about this recall
Is Wet-Field Hemostatic Eraser Bipolar, fine tip, straight, 5/SP recalled?
Yes. Beaver-Visitec International recalled Wet-Field Hemostatic Eraser Bipolar, fine tip, straight, 5/SP on 26 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1801-2018.
Why was it recalled?
Products were packaged with incorrect labeling,
Which lots are affected?
Lot number: 6001035
Where was it sold?
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 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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