Beaver-Visitec Anterior Chamber Cannula Recalled for Sharp Tip Needle
Beaver-Visitec International Inc. is recalling Visitec Anterior Chamber Cannulas because some units contain a sharp tip needle instead of a blunt tip cannula.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a sharp tip needle instead of a blunt tip, presenting a risk of injury during ophthalmic procedures, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Beaver-Visitec International Inc. is recalling 9,970 units of Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in), REF 585006. The recall is due to a manufacturing error where the product contains a sharp tip needle when it should contain a blunt tip cannula.
The affected units are from Lot number 3079324. These products were distributed nationwide, including to Alabama, Connecticut, Indiana, North Carolina, New York, Texas, and Virginia. The cannulae are intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye.
Healthcare providers and consumers should stop using the affected cannulas immediately. Users should contact Beaver-Visitec International Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula…
- Manufacturer
- Beaver-Visitec International Inc.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 9,970
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 3079324
Distribution
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