Recall Z-0228-2022
Beaver Visitec International, Inc. · initiated October 8, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
Codes / lots: Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834
Reason for recall
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-0228-2022
- Initiated
- October 8, 2021
- Product code
- OJK – Eye Tray
- Quantity
- 500 eaches
- Distribution
- Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
- Recalling firm
- Beaver Visitec International, Inc., Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0227-2022 Class II | Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract…Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades | 10/08/2021Open, Classified |
| Z-0229-2022 Class II | bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits…Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades | 10/08/2021Open, Classified |
| Z-0230-2022 Class II | bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent…Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades | 10/08/2021Open, Classified |