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Applied Medical Resources Corp recalls Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IR
Recalled October 3, 2012 · FDA recall Z-2448-2012 · Applied Medical Resources
Hazard
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. · FDA Class II
Units
40,238 units for all products in Recall Event
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Applied Medical Resources Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →