Reported May 13, 2020 · Terminated
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V;…
Applied Medical Resources Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R |
| 2 | CE0380DR/(01)H699CE0380DR10V |
| 3 | CE0440DR/(01)H699CE0440DR10S |
| 4 | CE0480DR/(01)H699CE0480DR10W |
| 5 | CE0540DR/(01)H699CE0540DR10T |
| 6 | CE0580DR/(01)H699CE0580DR10X |
| 7 | CE0680DR/(01)H699CE0680DR10Y |
- Lot codes and dates
14 of 14 products
Products covered by this recall Model / number Product as published CE0340DRBARD CATHETER — lot numbers 1276248, 1283930, 1284935, 1286527, 1295731, 1317372, 1326198 CE0380DRBARD CATHETER — lot numbers 1253338, 1260036, 1263505, 1268151, 1276218, 1283938, 1289018, 1299712, 1301797, 1308727, 1312145, 1314562, 1324334, 1335171 CE0440DRBARD CATHETER — lot number 1286829 CE0480DRBARD CATHETER — lot numbers 1263515, 1268153, 1276227, 1283943, 1284950, 1289021, 1293173, 1299711, 1301798, 1308737, 1312147, 1312986, 1318084, 1325785 CE0540DRBARD CATHETER — lot numbers 1284054, 1284951, 1328361 CE0580DRBARD CATHETER — lot numbers 1255414, 1263517, 1276230, 1283948, 1286831, 1289126, 1295732, 1301799, 1308735, 1317737, 1318091, 1325790, 1335172 CE0680DRBARD CATHETER — lot numbers 1250869, 1260041, 1268157, 1276234, 1283950, 1284954, 1289024, 1295730, 1303736, 1308740, 1314577, 1318092, 1324358 - Amount recalled
- 28,799 catheters in total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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