Recall Z-1066-2019— Beaver Visitec
Class II · Terminated
Class II FDA medical device recall by Beaver Visitec, initiated 2018-11-30, terminated 2020-05-01. FDA's recall record names no specific 510(k) clearance for this event. Product: BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).. Reason: Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury..
- Recalling firm
- Beaver Visitec
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-30
- Terminated
- 2020-05-01
- Firm location
- Waltham, MA, United States
Product description
BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
Reason for recall
Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.