—#193864

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

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: UDI-DI: 30886158010488 Lot Number: 6045693

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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: ClaimsUS@bvimedical.com or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday)

Recalling firm

Firm: Beaver Visitec International, Inc.
Address: 500 Totten Pond Rd, 10, City Point Waltham, Massachusetts 02451-1916

Distribution

Distribution pattern: US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA.

Timeline

Recall initiated: 2022-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193864. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.