FDAFDA · Food and drugs·Recall number Z-0527-2015
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
Published December 17, 2014 · Recall initiated: November 11, 2014
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
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alcon Research, Ltd.
- Distributor
- Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
- Lot
- Lot numbers 061814-95 and 080614-91
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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