PlainRecordsFDA · Medical device recall
Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item… and 2 more products
- Date posted by the FDA
- June 27, 2007
- Status
- Terminated
- Filed by
- Oasis Medical Inc
- Reason
- Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.
- Distribution pattern
- Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
3 products in this recall
Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals…
- Product
- 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.
- Quantity
- 3050 total for all item numbers
- Codes and lots
- ltem Number #1719 Bimanual Irrigation/Aspiration Set 19 Gauge: DB0l05A,DB0I06B,DB0605A,DB0605D,DB0705A,DB0804A,DB0804A; Item Number #1719-A Disposable Bimanual Aspiration Handpiece 19g: DB1004E; ltem #1719-I Disposable Bimanual Irrigation Handpiece 19g: DB0505A,DB0505A,DB0605C,DB0705H,DB1004D,DB1004E; Item Number: 1719-S: Bimanual I/A Hand Piece 19g Dual Port Smooth: DB0106C, DB0305A, DB0605B, DB0605E
- Recall started
- April 9, 2007
- Device type
- Device, Irrigation, Ocular Surgery
- Root cause (FDA)
- Other
- What the company told customers
- 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."
- Recall number
- Z-0740-2007
Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable Bimanuals…
- Product
- Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable Bimanuals Irrigation/Aspiration Set 20 Gauge, Dual Port; Item #1720-A - Disposable Bimanual Aspiration Handpiece 20g; Item #1720-I Disposable Bimanuals Irrigation/Aspiration Set 20g, Open End; Item #1720-S Disposable Bimanuals Irrigation/Aspiration Set, 20g, Dual Port, Smooth. For use in cataract surgical procedures.
- Quantity
- 3050 total for all item numbers
- Codes and lots
- ltem #1720 Bimanual Irrigation/Aspiration Set 20 Gauge: DB0105B, DB0l06A, DB0605F, DB0705J, DB0705J, DB0804B, DB0804B, DB1005A, DB1104H, DB1104I; Item #1720-A Disposable Bimanual Aspiration Handpiece 20g: DB1004I; ltem # 1720-I Disposable Bimanual Irrigation Handpiece 20g: DB0105D, DB0305A, DB0305A, DB0705B, DB0705I, DB1004H; Item #1720-S Disp Bimanual l/A Set 20g Dual Port Smooth: DB0505B, DB0505B, DB0605G, DB0705K, DB1205C
- Recall started
- April 9, 2007
- Device type
- Device, Irrigation, Ocular Surgery
- Root cause (FDA)
- Other
- What the company told customers
- 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."
- Recall number
- Z-0741-2007
Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals…
- 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.
- Quantity
- 3050 total for all item numbers
- Codes and 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
- Recall started
- April 9, 2007
- Device type
- Device, Irrigation, Ocular Surgery
- Root cause (FDA)
- Other
- What the company told customers
- 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."
- Recall number
- Z-0742-2007
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0740-2007, Z-0741-2007, Z-0742-2007. The agency record governs; check it and the company before acting.