Recall Z-0742-2007

Oasis Medical Inc · initiated April 9, 2007

Terminated

Product

Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals Irrigation/Aspiration Set 21 Gauge, Dual Port; Item #1721-A - Disposable Bimanual Aspiration Handpiece 21g; Item #1721-I Disposable Bimanuals Irrigation/Aspiration Set, 21g, Open End; Item #1721-S Disposable Bimanuals Irrigation/Aspiration Set, 21g, Dual Port, Smooth. For use in cataract surgical procedures.

Codes / lots: Item #1721Bimanual Irrigation/Aspiration Set 21 Gauge: DB0105C,DB0105C,DB0605H,DB0705E, DB0804C,DB0804C,DB0905C,DB0906B,DB1104G,DB1104J; ltem #1721-A Disposable Bimanual Aspiration Handpiece 21g: DB1004G; ltem # 1721-I Disposable Bimanual lrrigation Handpiece 21g: DB0105E, DB0105E, DB0705G,DB1004F; Item #1721-S Disp Bimanual I\A Set 21g Dual Port Smooth: DB06051,DB0705F, DB0805B, DB0906A, DB1205B, DB1205D

Reason for recall

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

FDA-determined cause: Other

Action taken

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."

Details

Recall number
Z-0742-2007
Initiated
April 9, 2007
Posted by FDA
June 27, 2007
Terminated
October 6, 2011
Product code
KYG – Device, Irrigation, Ocular Surgery
Quantity
3050 total for all item numbers
Distribution
Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
Recalling firm
Oasis Medical Inc, Glendora, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0740-2007 Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable…Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic… 04/09/2007Terminated
Z-0741-2007 Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable…Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic… 04/09/2007Terminated