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
- Recall Initiated
- October 24, 2019
- Posted
- May 7, 2020
- Terminated
- June 1, 2023
- Recall Number
- Z-1847-2020
- Quantity
- 28,799 catheters in total
- Firm Location
- Margarita, CA
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.
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
Lot / Code Info
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
Root Cause
Component change control
Action Taken
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.