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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

Product Description Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.
Recall Number Z-2448-2012
Classification Class II
Code Info Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.
Product Distributed Qty 40,238 units for all products in Recall Event
Reason For Recall Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Event Detail

Event Id 63100
Product Type Devices
Status Ongoing
Recalling Firm Applied Medical Resources Corp
City Rancho Santa Margarita
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.