Home / Recalls / Applied Medical Resources Corp / Z-1846-2020

Z-1846-2020 Class I Terminated

Recalled by Applied Medical Resources Corp — Rancho Santa Margarita, CA

Recall Details

Product Type
Devices
Report Date
May 13, 2020
Initiation Date
October 24, 2019
Termination Date
June 1, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28,799 catheters in total

Product Description

Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483

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.

Distribution Pattern

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

Code Information

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

Other recalls by Applied Medical Resources Corp

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  • Z-1389-2024 Class II — Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following (January 30, 2024)
  • Z-1388-2024 Class II — Epix Universal Clip Applier, REF: CA500, STERILEEO (January 30, 2024)
  • Z-2159-2020 Class II — Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UD (March 17, 2020)
  • Z-2160-2020 Class II — DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 (March 17, 2020)
  • Z-2158-2020 Class II — Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, U (March 17, 2020)
  • Z-2161-2020 Class II — Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) (March 17, 2020)
  • Z-2037-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607 (January 31, 2020)
  • Z-2034-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - P (January 31, 2020)
  • Z-2036-2020 Class II — STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - P (January 31, 2020)