FDAFDA · Food and drugs·Recall number Z-2096-2017
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.
Published May 24, 2017 · Recall initiated: March 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Distributor
- Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
- Lot
- Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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