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Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI recallZ-1847-2020 · Applied Medical Resources Corp · initiated Oct 24, 2019

Class I Terminated All recalls posted in May 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Applied Medical Resources Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Component change control

What the company is doing

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].

Recall details

Recall number
Z-1847-2020
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Oct 24, 2019
Posted by the FDA
May 7, 2020
Recalling firm
Applied Medical Resources Corp
Quantity
28,799 catheters in total
Product code
DXE
FDA submissions
K970762
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 description

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 (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

8 devices cleared under K970762 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85057).

Sources and updates

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