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U.S. Department of Health and Human Services

Class 2 Device Recall Embolectomy Catheters

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  Class 2 Device Recall Embolectomy Catheters see related information
Date Initiated by Firm August 09, 2012
Date Posted September 25, 2012
Recall Status1 Terminated 3 on March 22, 2013
Recall Number Z-2446-2012
Recall Event ID 63100
510(K)Number K901627  
Product Classification Catheter, embolectomy - Product Code DXE
Product Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX):
Model Numbers & Description:

A4402, 3F-40CM, SYNTEL RT-EMB;
A4403, 3F-80CM, SYNTEL RT-EMB;
A4404, 4F-40CM, SYNTEL RT-EMB;
A4405, 4F-80CM, SYNTEL RT-EMB;
A4406, 5F-80CM, SYNTEL RT-EMB;
A4407, 6F-80CM, SYNTEL RT-EMB;
A4408, 7F-80CM, SYNTEL RT-EMB;
A4F00, 2F-60CM (PREM) SYNTEL CATHETER;
A4F01, 2F-80CM, (PREM) SYNTEL CATHETER;
A4F02, 3F-40CM, (PREM) SYNTEL CATHETER;
A4F03, 3F-80CM, (PREM) SYNTEL CATHETER;
A4F04, 4F-40CM, (PREM) SYNTEL CATHETER;
A4F05, 4F-80CM, (PREM) SYNTEL CATHETER;
A4F06, 5F-80CM, (PREM) SYNTEL CATHETER;
A4F07, 6F-80CM, (PREM) SYNTEL CATHETER;
A4F08, 7F-80CM, (PREM) SYNTEL CATHETER;
CE0260ST, L2F-60CM PREM SYNTEL CATH;
CE0280ST, L2F-80CM PREM SYNTEL CATH;
CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER;
CE0380ST, 3F-80CM PREM SYNTEL CATH;
CE0440ST, 4F-40CM PREM SYNTEL CATH;
CE0480ST, 4F-80CM PREM SYNTEL CATH;
CE0580ST, 5F-80CM PREM SYNTEL CATH;
CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER;
CE0780ST, 7F-80CM PREM SYNTEL CATH;
CE0340, 3F-40cm, SYNTEL RT-EMB;
CE0380, 3F-80cm, SYNTEL RT-EMB;
CE0440, 4F-40cm, SYNTEL RT-EMB;
CE0480, 4F-80cm, SYNTEL RT-EMB;
CE0580, 5F-80cm, SYNTEL RT-EMB;
CE0680, 6F-80cm, SYNTEL RT-EMB;
CE0780, 7F-80cm SYNTEL RT-EMB.

BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
Code Information Model Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598. A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911. A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013. A4F07: 1171170, 1156271, 1167414, 1164151. A4F08: 1168855, 1155648. CE0260ST: 1164307, 1168569. CE0280ST: 1164351. CE0340ST: 1164348. CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032. CE0440ST: 1164336, 1168610. CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283. CE0580ST: 1164345, 1164346, 1168613. CE0680ST: 1164330, 1166470. CE0780ST: 1164354. CE0340: 1166904. CE0380: 1164344. CE0440: 1164347, 1168609. CE0480: 1164343. CE0580: 1164349. CE0680: 1164353 CE0780: 1169926.  
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa # 3
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact
949-713-8000
Manufacturer 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.
FDA Determined
Cause 2		 Material/Component Contamination
Action Applied Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to complete the attached Recall Notification Confirmation Form and to return it to the firm via e-mail to recall60476587@appliedmedical.com or fax to (949) 713-8832. For product return questions, customers were instructed to contact Sales Operations Administrator at (949) 713-8652.For questions regarding this recall contact the firm at (949) 713-8041.
Quantity in Commerce 40,238 units for all products in Recall Event
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXE and Original Applicant = APPLIED VASCULAR DEVICES, INC.
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