Python Embolectomy Catheters recall
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421…
Why was Python Embolectomy Catheters 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model A4E01, PYTHON 5MM-40CM, lot numbers 1259463, 1268371, 1274343, 1281314, 1288397, 1291497, 1302766, 1305919, 1312958, 1317578, 1319209, 1324383, 1326383, 1333050, 1338309, 1339544. Model A4E02, PYTHON 5MM-80CM, lot numbers 1257416, 1268372, 1281315, 1283401, 1293028, 1294897, 1303013, 1305920, 1317579, 1319807, 1324384, 1331435, 1332003, 1338732, 1339490 Model A4E03, PYTHON 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) Model A4E04, PYTHON 9MM-80CM, lot numbers 1255539, 1262756, 1269004, 1276316, 1281786, 1288847, 1293169, 1299257, 1303808, 1312595, 1319212, 1321387, 1325381, 1331884, 1332592, 1337686, 1339491 Model A4E05, PYTHON 11MM-40CM, lot numbers 1263092, 1268170, 1273184, 1278603, 1283650, 1288347, 1292823, 1296020, 1299013, 1305922, 1310451, 1318835, 1320036, 1323535, 1325777, 1330446, 1331328, 1337641, 1339492 Model A4E06, PYTHON 11MM-80CM, lot numbers 1261855, 1268451, 1276317, 1284924, 1290454, 1298079, 1305921, 1310623, 1320183, 1323280, 1330449, 1332579, 1337652, 1339493 Model A4E08, PYTHON 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 Model A4E09, PYTHON 14MM-80CM, lot numbers 1260019, 1273374, 1281783, 1283770, 1295466, 1299012, 1305368, 1317203, 1317876, 1319210, 1324390, 1330448, 1332593, 1337653, 1339495
- Product
- Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421…
- Recalling firm
- Applied Medical Resources Corp
- Quantity
- 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
- Recall date
- May 13, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)