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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics® Mini-Flared ABS® Tip, 20 Degree Tip Angle, 45° Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics® Tapered ABS® MicroTip" 30° Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000" Legacy® TurboSonics® Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.
Recall Number Z-1642-2013
Classification Class II
Code Info 122590, 123372, 123215, 122309.
Product Distributed Qty 90
Reason For Recall The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Event Detail

Event Id 65205
Product Type Devices
Status Ongoing
Recalling Firm Surgical Instrument Service And Savings, Inc.
City Redmond
State OR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.