Recalling Firm / Manufacturer

Oasis Medical Inc.

Product

Premier Edge MVR 20g Microsurgical Knife, Item PE-3520

Code Information

Lot #'s DK0107AJ, DK0107X, DK0307P

Reason of Recall

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

Date Recall Initiated

June 08, 2007

Action

Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once ofthis product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience.". Firm Initiated recall is ongoing.

Contact

Al-Basar Company
Riyadh
(01) 4616122

Source of Information

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.