Recall Z-1664-2014— Beaver-Visitec International Inc.
Class II · Terminated
Class II FDA medical device recall by Beaver-Visitec International Inc., initiated 2014-05-06, terminated 2014-09-05. FDA's recall record names no specific 510(k) clearance for this event. 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 is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth. Reason: Contains a sharp tip needle when the product should contain a blunt tip cannula.
- Recalling firm
- Beaver-Visitec International Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-06
- Terminated
- 2014-09-05
- Firm location
- Waltham, MA, United States
Product description
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 is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth
Reason for recall
Contains a sharp tip needle when the product should contain a blunt tip cannula
Data sourced from openFDA. This site is unofficial and independent of the FDA.