Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. 99.999% Reduction In-solution in 30 seconds. M
FDA device recall Z-0450-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Oculus Innovative Sciences Inc
- Reason for recall
- Unapproved drug claims and those not approved under 510K clearance.
- Action taken
- Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 2045 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-11-09
- Date posted
- 2012-01-11
- Date terminated
- 2012-12-07
- Location
- Petaluma, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER (K090206) | Oculus Innovative Sciences, Inc. | 2009-06-02 |
| MICROCYN WOUND CARE DRESSING (K041161) | Oculus Innovative Sciences, Inc. | 2005-05-03 |