Z-1066-2019 Class II Terminated
FDA device recall Z-1066-2019 was initiated by Beaver Visitec on November 30, 2018 and is designated Class II. 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… The recall status is terminated (terminated May 1, 2020). Affected quantity: 3430 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- November 30, 2018
- Termination Date
- May 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3430 units
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.
Distribution Pattern
Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.
Code Information
Lots 60047S4, 60060S9, 600623S