FDA-Device2017-05-24Class II
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
Abbott Medical Optics Inc. (AMO)
Hazard
Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
Sold states
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
Affected count
360 units total
Manufactured in
1700 E Saint Andrew Pl, Santa Ana, CA, United States
Products
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2096-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief