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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 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.
Recall Number Z-2447-2012
Classification Class II
Code Info Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.
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.