FDA Recall
Terminated
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.
Recall: Z-0527-2015
·
Initiated November 11, 2014
Recall
- Recall Number
- Z-0527-2015
- Event Number
- 69743
- Firm
- Alcon Research, Ltd.
- FEI Number
- 1610287
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 11, 2014
- Posted
- December 12, 2014
- Terminated
- February 4, 2016
- Address
- 6201 South Fwy Fort, Worth, TX, 76134-2099
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
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
Action
On November 11, 2014, the firm sent letters to their customers notifiying them of the medical device recall. The recalling firm asked their customers to stop using the recalled product, remove it from inventory, return the affected product, and complete a response form.
Distribution
Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
Quantity
2321