Reported May 13, 2020 · Terminated
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414;…
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?
8 of 8 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 00607915113407 | Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407 |
| 2 | 00607915113414 | A4E02/(01)00607915113414 |
| 3 | 00607915113421 | A4E03/(01)00607915113421 |
| 4 | 00607915113438 | A4E04/(01)00607915113438 |
| 5 | 00607915113445 | A4E05/(01)00607915113445 |
| 6 | 00607915113452 | A4E06/(01)00607915113452 |
| 7 | 00607915113476 | A4E08/(01)00607915113476 |
| 8 | 00607915113483 | A4E09/(01)00607915113483 |
- Lot codes and dates
17 of 17 products
Products covered by this recall Model / number Product as published A4E01PYTHON 5MM-40CM — lot numbers 1259463, 1268371, 1274343, 1281314, 1288397, 1291497, 1302766, 1305919, 1312958, 1317578, 1319209, 1324383, 1326383, 1333050, 1338309, 1339544. A4E02PYTHON 5MM-80CM — lot numbers 1257416, 1268372, 1281315, 1283401, 1293028, 1294897, 1303013, 1305920, 1317579, 1319807, 1324384, 1331435, 1332003, 1338732, 1339490 A4E03PYTHON 9MM-40CM — lot numbers 1256874,1263093,1269005,1276315,1281787,1287079,1298430,1303017, 1308139, 1319211, 1330447, 1331896, 1333407, 1337644, 1341362 (note — lot numbers edited for correctness 4/23/2021) A4E04PYTHON 9MM-80CM — lot numbers 1255539, 1262756, 1269004, 1276316, 1281786, 1288847, 1293169, 1299257, 1303808, 1312595, 1319212, 1321387, 1325381, 1331884, 1332592, 1337686, 1339491 A4E05PYTHON 11MM-40CM — lot numbers 1263092, 1268170, 1273184, 1278603, 1283650, 1288347, 1292823, 1296020, 1299013, 1305922, 1310451, 1318835, 1320036, 1323535, 1325777, 1330446, 1331328, 1337641, 1339492 A4E06PYTHON 11MM-80CM — lot numbers 1261855, 1268451, 1276317, 1284924, 1290454, 1298079, 1305921, 1310623, 1320183, 1323280, 1330449, 1332579, 1337652, 1339493 A4E08PYTHON 13MM-80CM — lot numbers 1252636, 1259464, 1263484, 1265630, 1266989, 1267854, 1268688, 1276314, 1281784, 1283399, 1287076, 1290936, 1294898, 1303211, 1306288, 1308127, 1312957, 1315919, 1317577, 1319637, 1320236, 1324382, 1332433, 1335657, 1339494 A4E09PYTHON 14MM-80CM — lot numbers 1260019, 1273374, 1281783, 1283770, 1295466, 1299012, 1305368, 1317203, 1317876, 1319210, 1324390, 1330448, 1332593, 1337653, 1339495 - 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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