INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An op
FDA device recall Z-1597-2016 · posted 2016-05-03 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
- Action taken
- The recalling firm notified affected customers on 10/6/2014 via a customer letter with an attached Medical Device Removal Response Form. On 10/23/2014, a second notification was sent to 76 customers who did not respond to the initial notification.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 6597 packs
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-10-06
- Date posted
- 2016-05-03
- Date terminated
- 2017-03-31
- Location
- Fort Worth, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINITI (K021566) | Alcon Laboratories, Inc. | 2002-07-02 |