—#207924

Product

Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227

FDA product code: HNN — Knife, Ophthalmic
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: UDI-DI: 00886158001652; Lot Number: 6058854

Why it was recalled

The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).

Root cause (FDA determination)

Process control

Action the firm took

An URGENT Field Safety Notice dated 5/10/24 was sent to customers. Actions Required by You Our records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots. PLEASE perform the following actions: 1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. In case you purchased the CustomEye Kit please be advised it is not possible to check the bevel orientation without losing the KIT sterility. In such case, immediately put the KIT out of use. 2. In case a non-conforming product is identified please quarantine it and return ALL quarantined product from the affected lots to our company via pre-paid postal labels, supplied to you with an initial notification 3. 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. 4. Review the enclosed Business Reply Form (BRF) and indicate whether you have the affected product in your possession. 5. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) destroyed. 6. Return the completed BRF to BVI by emailing the attached to bvi5577@sedgwick.com (U.S based customers) or to FA-24-002XstarOUS@Sedgwick.com (rest of the world based customers). BVI values your business and apologizes for the inconvenience this may have caused. Please direct any questions regarding credit to our customer service department by email and include in the subject line: Master Case PIR 00564835. Country Customer Service Email UK UKCustomerSupport@bvimedical.com FR serviceclient@bvimedical.com DE/ AT Kundendienst@bvimedical.com IT servizioclienti@bvimedical.com ROW ROWCustomerSupport@bvimedical

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.

Timeline

Recall initiated: 2024-05-10
Posted by FDA: 2024-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207924. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.