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Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cat...

FDA Recall #Z-0782-2023 — Class II — November 30, 2022

Recall #Z-0782-2023 Date: November 30, 2022 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Beaver Visitec International, Inc. — Waltham, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

599 units (US): 410 units; 189 kits

Distribution

US Nationwide distribution.

Code Information

UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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