Recall Z-0449-2012 ยท FRO Dressing, Wound, Drug
Oculus Innovative Sciences Inc
Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. Does not contain Antibiotics, Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around eyes, nose, m mouth and open wounds - Accelerated healing of mi
| Date | Jan 11, 2012 (initiated Nov 9, 2011) |
| Status | Terminated |
| Reason | Unapproved drug claims and those not approved under 510K clearance. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 7894 x 8 oz pumps; 174 x 16 oz pumps |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090206 | OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER Oculus Innovative Sciences, Inc., Jun 2, 2009 |