Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals Irrigation/Aspiration Set

FDA device recall Z-0742-2007 · posted 2007-06-27 · Terminated

Recall details

Recalling firm

Oasis Medical Inc

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.

Action taken

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

Status

Terminated

Product code

KYG

Quantity affected

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.

Date initiated

2007-04-09

Date posted

2007-06-27

Date terminated

2011-10-06

Location

Glendora, CA