| Class 2 Device Recall BVI Beaver Xstar Crescent Knife | |
Date Initiated by Firm | October 08, 2021 |
Create Date | November 16, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0227-2022 |
Recall Event ID |
88826 |
Product Classification |
Knife, ophthalmic - Product Code HNN
|
Product | Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery.
REF#: 373809 |
Code Information |
LOT#: 6000842, 6002045, 6011609, 6034238, 6040517, 6042907.
UDI:
" Primary: 00886158000594
" Secondary: 30886158000595
" Tertiary: 50886158000599
|
Recalling Firm/ Manufacturer |
Beaver Visitec International, Inc. 500 Totten Pond Rd 10 City Point Waltham MA 02451-1916
|
For Additional Information Contact | SAME 781-906-7950 |
Manufacturer Reason for Recall | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades |
FDA Determined Cause 2 | Under Investigation by firm |
Action | BVI notified Consignees by Urgent Medical Device Recall letter on 10/8/21 via registered mail. Letter states 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 subrecall.
Consider all potential users of this product in your user supply chain. You are encouraged to a copy of this recall notification letter when contacting your customers.
2. Complete the enclosed Business Reply 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 the completed BRF to BVI by one of these methods:
" Fax to 866-552-4919
" Email the attached to beavervisitec3997@sedgwick.com
5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label:
Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241
Attn: Event 3997
If you received this notification without the prepaid UPS label and Business Reply Form (BRF), and require additional shipping labels, or if you have questions regarding the return procedure, please contact Stericycle Inc. at 866-606-8264 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time).
Please direct any questions regarding this matter to our customer service department by email ClaimsUS@bvimedical.com and please include in the subject line: Master Case PIR 263383 |
Quantity in Commerce | 5950 eaches |
Distribution | Nationwide
Foreign:
Australia
Austria
France
Germany
Netherlands
Spain
Japan
Russia
South Africa
UK
|
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|