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U.S. Department of Health and Human Services

Class 1 Device Recall Bard Dual Lumen Embolectomy Catheter

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  Class 1 Device Recall Bard Dual Lumen Embolectomy Catheter see related information
Date Initiated by Firm October 24, 2019
Date Posted May 07, 2020
Recall Status1 Open3, Classified
Recall Number Z-1847-2020
Recall Event ID 85057
510(K)Number K970762  
Product Classification Catheter, embolectomy - Product Code DXE
Product Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI:
CE0340DR/(01)H699CE0340DR10R;
CE0380DR/(01)H699CE0380DR10V;
CE0440DR/(01)H699CE0440DR10S;
CE0480DR/(01)H699CE0480DR10W;
CE0540DR/(01)H699CE0540DR10T;
CE0580DR/(01)H699CE0580DR10X;
CE0680DR/(01)H699CE0680DR10Y
Code Information Model CE0340DR, BARD CATHETER, lot numbers 1276248, 1283930, 1284935, 1286527, 1295731, 1317372, 1326198  Model CE0380DR, BARD CATHETER, lot numbers 1253338, 1260036, 1263505, 1268151, 1276218, 1283938, 1289018, 1299712, 1301797, 1308727, 1312145, 1314562, 1324334, 1335171  Model CE0440DR, BARD CATHETER, lot number 1286829  Model CE0480DR, BARD CATHETER, lot numbers 1263515, 1268153, 1276227, 1283943, 1284950, 1289021, 1293173, 1299711, 1301798, 1308737, 1312147, 1312986, 1318084, 1325785  Model CE0540DR, BARD CATHETER, lot numbers 1284054, 1284951, 1328361  Model CE0580DR, BARD CATHETER, lot numbers 1255414, 1263517, 1276230, 1283948, 1286831, 1289126, 1295732, 1301799, 1308735, 1317737, 1318091, 1325790, 1335172  Model CE0680DR, BARD CATHETER, lot numbers 1250869, 1260041, 1268157, 1276234, 1283950, 1284954, 1289024, 1295730, 1303736, 1308740, 1314577, 1318092, 1324358   
Recalling Firm/
Manufacturer
Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact Jaclene Rios-Simpson
949-713-8688
Manufacturer Reason
for Recall
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
FDA Determined
Cause 2
Component change control
Action On November 08, 2019, a "Urgent: Medical Device Recall" letter was sent via UPS to all affected customers. In addition to providing information on the recalled products, the letter asked customers to do the following: 1. Check your inventory for the recalled product. 2. Complete the Recall Notification Confirmation Form to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above. 3. If no product is being returned, please indicate on the Recall Notification Confirmation Form. 4. If you are a distributor, please notify any facilities to which you distributed the affected product. Please also complete Page 4 of the Recall Notification Confirmation Form. 5. Return the Recall Notification Confirmation Form to Applied Medical by email to recall60810330@appliedmedical.com or faxing it to (949) 713-8908. 6. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical (Product Return Instructions are on Page 5). 7. For product return questions, please contact Jaclene Rios-Simpson, Senior Manager, Customer Relations at (949) 713-8688 or jrios@appliedmedical.com. 8. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or lcontursi@appliedmedical.com.
Quantity in Commerce 28,799 catheters in total
Distribution Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXE and Original Applicant = APPLIED MEDICAL RESOURCES
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