Z-1801-2018Class II

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

Name: Z-1801-2018 Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Creator: Beaver-Visitec International Inc.
Published: 2018-02-26
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-02-26 / Terminated / root cause: labeling and UDI

FDA source

Beaver-Visitec International Inc. began a recall of Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549 on 2018-02-26. FDA classified it as Class II and gives the reason as "Products were packaged with incorrect labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1801-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-26
Posted: 2018-05-10
Terminated: 2019-10-30
Recalling firm: Becton Dickinson & Co
Product: Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Products were packaged with incorrect labeling,
Root cause tag: labeling and UDI
FDA 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 in commerce: 1025
Distribution: US Nationwide and Canada
Product codes and lots: Lot number: 6001035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1801-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1801-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10

Product code GEI

K911160Class IIMentor(r) Wet-Field(r) II Ac Coagulator, 22-1305Mentor O & O, Inc. / cleared 1991-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)