Recall Z-0742-2007 ยท KYG Device, Irrigation, Ocular Surgery
Oasis Medical Inc
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 proce
| Date | Jun 27, 2007 (initiated Apr 9, 2007) |
| Status | Terminated |
| Reason | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| Root cause | Other |
| Action | 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." |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.