—#197315

Product

Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630

FDA product code: HNN — Knife, Ophthalmic
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035

Why it was recalled

Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Beaver Visitec (BVI) issued Urgent Medical Device Recall Letter (FA-22-006) on 11/30/22 via certified mail to Distributors/Customers. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from the lot that is subject to this 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. Use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product to return. Please return the business reply form to Beavervisitec6269@sedgwick.com. 3. Please enter the following information on the enclosed BRF: company name, part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. If you have any questions regarding this Field Action, please contact BVI at 888-708-5723 or Beavervisitec6269@sedgwick.com. If you have affected product, please return product with copy of BRF to: Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Attn: Event 6269 Stericycle 2670 Executive Drive, Suite A, Indianapolis, IN 46241 Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please direct any questions regarding credit to our customer service department by email ClaimsUS@bvimedical.com and include in the subject line: Master Case PIR: 387823.

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.

Timeline

Recall initiated: 2022-11-30
Posted by FDA: 2023-01-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197315. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.