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Terminated

Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton.

FDA Recall Z-1224-06 · Posted 2006-08-02

Recalling FirmMedisurg Research & Management Corp
Recall StatusTerminated
Product CodeNCR
Date Initiated2006-04-28
Date Terminated2006-09-08
Product Quantity960 tips

Reason for Recall

No documentation to support shelf life/sterility

Firm Action

On 4/28/06, the recalling firm faxed a notification to the customers informing them not to use the product during surgery and to return the product.

Root Cause

Other

Distribution Pattern

Nationwide, including CA, CT, FL, GA, MA, NC, NY, OH, OR, PA, TX, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001498THE FUGO BLADEMedisurg , Ltd. · 2000-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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