LOT NUMBER(S): 1121612, 1121974, 1121863, 1122208

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT; Model Number: K2154 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121372

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE ; Model Number: K2155 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121401

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

Model: Model Numbers: A4403, A4405, A4406, A4407, A4752, A4F00, A4F01, A4F02, A4F03, A4F04, A4F05, A4F06, A4F07, A4F08., Affected: 48 lots

Trocars are assembled into procedure kits. Trocars have thier own serial number but the kit lots are relevant and include:  45036301001 to 45036301007 containing 1 each of lot 126803 = 71 each; 45208001001 to 452084001008 containing 1 each of lot 127322=8 each; 452451005001 to 452451005003 containing 1 each of lot 127322=3 each; 453029001001 to 453029001017 containing 1 each of lot 127322 = 17 each; 453715004002 containing 1 each of lot 126803 = 1 each; 454116005001 to 454116005002 containing 1 each of lot 127322 = 2; 454608003001 to 454608003006 containing 1 each of lot 172528 = 6 each.

Obstetrical and Gynecological Devices

2

No

Nationwide. Ireland.

Applied Blunt Tip Trocar || Models C0717 and C0718

Injections / Infusions / Transfusions / Dialysis - catheters

A47XX; CB0XXXXX | see FSN

MD: Drainage biliary catheter; Embolectomy/thrombectomy catheter; Cholangiopancreatography catheter, single-use

Applied Medical Resources: CA090, Direct Drive® Clip Applier 3/BX

Catalog Number: 100975401; 101416101 Model Number: CA090 and any associated kits including the CA090 Batch Number: 1190640 1191260 1191261 1191369 1192248 1191425 1192573 1192574 1193046 1193175 1193435 1193512 1194493 1194494 1195770 1195771 1195792 1195793 1196010 1196014 1196211 1196210 1196361 1196687 1196362 1196686 1196688 1196719 1196735 1196736 1196737 1196805 1197159 1197913 1197826 1197827 1197825 1197915 1197916 1197914 1197918 1198995 1198996 1198997 1199797 1199798 1199851 1200211 1200212 1199852 1200414 1200213 1200589 1201543 1201565 1201885 1201886 1200713 1201982 1202651 1202652 1202979 1203113 1203114 1203135 1203291 1203560 1203729 1204085 1204608 1204797 1204798 1205062 1205681 1205682 1206045 1205465 1206046 1206549 1207309 1207320 1206434 1207746 1207744 1207745 1207749 1209141 1209142 1209143 1209155 1209144 1209156 1209552 1209768 1209859 1210512 1209941 1210851 1210998 1211597 1211038 1211039 1211050 1211886 1212666 1212768 1213133 1213318 1214521 1215840 1216197 1217070 1217759 1218289 1218680 1219647 1216169 1216180 1216181 1218682 1218683 1221320 1221468 1223112 1221737 1222986 1222987 1223891 1226026 1224185 1224485 1224486 1227284 1227290 1228149 1227674 1224395 1228544 1228555 1229106 1229365 1230972 1232955 1229867 1229866 1233475 1230403 1233476 1232741 1234102 1234360 1234374 1234761 1235799 1235901 1236014 1236009 1236552 1237475 1237565 1238425 1234103 1237567 1237568 1238513 1239837 1238600 1238621 1238142 1239402 1239431 1240610 1240611 1241091 1242200 1241094 1241859 1242585 1242586 1243587 1244385 1244386 1244387 1245992 1245710 1243604 1244232 1246219 1247895 1249462 1250211 1249463 1251406 1251459 1252764 1253479 1253491 1253490 1254855 1255697 1255698 1257562 1253273 1257642 1257643 1257794 1258172 1258305 1258306 1258613 1258730 1258944 1259220 1259221 1259222 1259004 1259017 1259046 1262387 1262388 1261739 1261905 1262795 1262797 1263340 1263342 1263601 1263957 1263958 1263438 1264087 1262389 1258614 1264491 1264913 1265006

Inactive implantable medical devices

Medical instruments for use in humans - visceral surgery

medical_device

Medical instruments for use in humans - general instruments

Applied Medical: CA500, Epix® Universal Clip Applier 3/BX

Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy

Applied Medical: CFF05 5x75mm Kii Fios Advanced Fixation Access Sys

CA090 with expiration date prior to March 18, 2019, lots 1190181 through 1265006.

It is indicated for ligating vessels that, in the opinion of the surgeon, require a medium or large size ligature clip.

Product/Kit Batch Numbers: 1061480, 1061127, 1060184, 1058796, 1058108, 1056578, 1056709, 1054094, 1054837

Obstetrical and Gynecological Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

Product/Kit Batch Numbers: 1061115, 1058102, 1057096

Obstetrical and Gynecological Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Product/Kit Batch Number 1059804

Obstetrical and Gynecological Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

Product/Kit Batch Numbers: 1060178, 1056644, 1056045

Obstetrical and Gynecological Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.