FDA-Device2012-10-03Class II
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
Applied Medical Resources Corp
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.
Sold states
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.
Affected count
40,238 units for all products in Recall Event
Manufactured in
22872 Avenida Empresa # 3, N/A, Rancho Santa Margarita, CA, United States
Products
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2447-2012Don't want to check this manually?
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