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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Bimanual Irrigation and Aspiration Handpiece Set:

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 Class 2 Device Recall Disposable Bimanual Irrigation and Aspiration Handpiece Set:see related information
Date Initiated by FirmApril 09, 2007
Date PostedJune 27, 2007
Recall Status1 Terminated 3 on October 06, 2011
Recall NumberZ-0740-2007
Recall Event ID 38120
Product Classification ophthalmic irrigation and aspiration - Product Code KYG
ProductDisposable 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.
Code Information 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
Recalling Firm/
Manufacturer		 Oasis Medical Inc
510-528 South Vermont Ave
Glendora CA 91741
For Additional Information ContactRobyn Scopis
626-852-5156
Manufacturer 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 Determined
Cause 2		Other
ActionAn 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 Commerce3050 total for all item numbers
DistributionWorldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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