Recall Z-0527-2015— Alcon Research, Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research, Ltd., initiated 2014-11-11, terminated 2016-02-04. It names 2 FDA 510(k) clearances: K934320, K880863. Product: 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.. Reason: The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-11
- Terminated
- 2016-02-04
- Firm location
- Fort Worth, TX, United States
510(k) clearances named in this recall
2 on FDA's record- K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
- K880863 — BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.