Z-1847-2020Class I

Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R...

Name: Z-1847-2020 Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R...
Creator: Applied Medical Resources Corp
Published: 2019-10-24
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2019-10-24 / Terminated

FDA source

Applied Medical Resources Corp began a recall of Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S... on 2019-10-24. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1847-2020
Classification: Class I
Status: Terminated
Initiated: 2019-10-24
Posted: 2020-05-07
Terminated: 2023-06-01
Recalling firm: Applied Medical Resources Corp
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
Product code: DXE Catheter, Embolectomy
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 root cause: 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 [email protected] 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 [email protected]. 8. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or [email protected].
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1847-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1846-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07
Z-1847-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07
Z-1848-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07

Product code DXE

K970762Class IIDual Lumen Embolectomy CatheterApplied Medical Resources / cleared 1997-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)