Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bip
FDA device recall Z-0527-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 2321
- Distribution
- Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
- Date initiated
- 2014-11-11
- Date posted
- 2014-12-12
- Date terminated
- 2016-02-04
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION (K934320) | Mentor O & O, Inc. | 1994-02-16 |
| BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 (K880863) | New England Surgical Instrument Corp. | 1988-04-19 |