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.
FDA Recall Z-0740-2007 · Posted 2007-06-27
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Recalling FirmOasis Medical Inc
Recall StatusTerminated
Product CodeKYG
Date Initiated2007-04-09
Date Terminated2011-10-06
Product Quantity3050 total for all item numbers
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.
Firm 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."
Root Cause
Other
Distribution Pattern
Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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