Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 2
FDA device recall Z-1940-2015 · posted 2015-06-29 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
- Action taken
- Recall notification letters were sent to consignees on June 2, 2015.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 35,475 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, Internati
- Date initiated
- 2015-06-02
- Date posted
- 2015-06-29
- Date terminated
- 2017-04-20
- Location
- Fort Worth, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI OPHTHALMIC SURGERY SYSTEM (K911808) | Alcon Laboratories | 1991-06-25 |