Recalls / —
—#163934
Product
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K911160
- Affected lot / code info
- Lot number: 6001035
Why it was recalled
Products were packaged with incorrect labeling,
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
On 2/26/18 Beaver-Visitec emailed product recall notices to affected customers. Customers were instructed to destroy the affected product, provide objective evidence of the product destruction, then complete and return the customer response form. Customers with questions regarding this recall may contact Customer Service at (866)906-8080.
Recalling firm
- Firm
- Beaver-Visitec International Inc.
- Address
- 500 Totten Pond Rd, Waltham, Massachusetts 02451-1916
Distribution
- Distribution pattern
- US Nationwide and Canada
Timeline
- Recall initiated
- 2018-02-26
- Terminated
- 2019-10-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #163934. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.