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FDA Medical Device Recalls (openFDA)

Beaver-Visitec International Inc.: Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549

Recall number
Z-1801-2018
Recalling firm
Beaver-Visitec International Inc.
Product
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Status
Terminated
Initiated
2018-02-26
Posted
not on file
Terminated
2019-10-30
Reason
Products were packaged with incorrect labeling,
Root cause
Labeling mix-ups
Action
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.
Quantity
1025
Distribution
US Nationwide and Canada
Lot, serial or model codes
Lot number: 6001035
510(k) numbers
["K911160"]
PMA numbers
not on file
Product code
GEI
Firm FEI
1211998
Firm city
Waltham
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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