Oasis Medical Inc Recalls

Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.

Labeling: Missing Label; The label on the immediate bottle is missing.

OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight .25mm ports (four per tip).

"Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators

OASIS Medical shall inform all customers that have received the product via FAX and Certified Mail to cease use immediately and return all unused product to OASIS.

Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A - Disposable Bimanual Aspiration Handpiece 19g; Item #1719-I Disposable Bimanuals Irrigation/Aspiration Set, 19g, Open End; Item #1719-S Disposable Bimanuals Irrigation/Aspiration Set, 19g, Dual Port, Smooth. For use in cataract surgical procedures.

Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.

An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) 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 of this product recall. Your notification to your customers may be enhanced by induding 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."

OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)

Labeled with an incorrect diameter

OASIS Medical informed all customers via FAX and Certified Mailt that received the product that the firm was voluntarily recalling one lot of the SOFT PLUG Extended Duration Plugs (REF 6403) and to cease use immediately. Customers are advised to check their inventory and return any remaining and return all unused product to OASIS Medical SOFT PLUG Extended Duration Plugs (REF 6403) from Lot LA1105E by FedEx. Customers are also advised that if they have used the product, to inform OASIS Medical of the number of samples of this lot used for an accurate account of the product distributed, used and returned.

Premier Edge MVR 19g Microsurgical Knife, Item PE-3519

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.

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."

Disposable Angled MVR Blade (23 gauge/0.6mm), REF/Item Code: 1282D0.6 , OASIS, Glendora, CA.

Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL

A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS Medical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.