Z-0740-2007

Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals...

Name: Z-0740-2007 Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals...
Creator: Oasis Medical Inc
Published: 2007-04-09
License: https://open.fda.gov/license/

Oasis Medical, Inc. / initiated 2007-04-09 / Terminated

FDA source

Oasis Medical Inc began a recall of Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A -... on 2007-04-09. The reason FDA records is "Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0740-2007
Status: Terminated
Initiated: 2007-04-09
Posted: 2007-06-27
Terminated: 2011-10-06
Recalling firm: Oasis Medical, Inc.
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.
Product code: KYG Device, Irrigation, Ocular Surgery
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 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 in commerce: 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.
Product 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

Product code KYG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)