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
- Recall Initiated
- April 26, 2022
- Recall Number
- Z-1281-2022
- Quantity
- 660 units
- Firm Location
- City Point Waltham, MA
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
Distribution
US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA.
Lot / Code Info
UDI-DI: 30886158010488 Lot Number: 6045693
Root Cause
Under Investigation by firm
Action Taken
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)