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Wet-Field Eraser recallZ-1281-2022 · Beaver Visitec International, Inc. · initiated Apr 26, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beaver Visitec International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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)

Recall details

Recall number
Z-1281-2022
Status
Open, Classified
Initiated by the company
Apr 26, 2022
Recalling firm
Beaver Visitec International, Inc.
Quantity
660 units
Product code
GEI
FDA submissions
K911160
Distribution
US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 30886158010488 Lot Number: 6045693

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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