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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID 62945
Product Type Devices
Status Ongoing
Recalling Firm Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
City Aguadilla
State PR
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-15
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery MAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, MAQD910 Class II Potential for bent tips. 117,948 units (total) Z-0204-2013
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery MABQ150, MAGS310, MAJC690 Class II Potential for bent tips. 117,948 units (total) Z-0203-2013
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170 Class II Potential for bent tips. 117,948 units (total) Z-0202-2013
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery MAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740 Class II Potential for bent tips. 117,948 units (total) Z-0201-2013
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