Z-1281-2022Class II

BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of...

Name: Z-1281-2022 BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of...
Creator: Beaver Visitec International, Inc.
Published: 2022-04-26
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-04-26 / Open, Classified / root cause: labeling and UDI

FDA source

Beaver Visitec International, Inc. began a recall of BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251 on 2022-04-26. FDA classified it as Class II and gives the reason as "Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1281-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-26
Posted: 2022-06-23
Recalling firm: Becton Dickinson & Co
Product: BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: BVI issued Urgent Medical Device Letter dated 4/26/22 via email stating reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return ALL quarantined product from the affected lot to our company utilizing the Return Merchandise Authorization (RMA) sticker label that is included with this letter. You may use the prepaid BVI FedEx number for your return. If you have any specific product replacement questions you may contact our Customer Service Team at: [email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday)
Quantity in commerce: 660 units
Distribution: US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA.
Product codes and lots: UDI-DI: 30886158010488 Lot Number: 6045693

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1281-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1281-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-29	2022-06-22

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)