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.
- Company
- Oasis Medical, Inc.
- Recall Initiated
- April 9, 2007
- Posted
- June 27, 2007
- Terminated
- October 6, 2011
- Recall Number
- Z-0742-2007
- Quantity
- 3050 total for all item numbers
- Firm Location
- Glendora, CA
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.
Distribution
Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
Lot / Code Info
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
Root 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."