FDA Device recall Z-1621-2016
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures
- FDA Device
- Class II
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures by Applied Medical Resources, citing increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1621-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-01 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Applied Medical Resources |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WY |
Product
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
Reason
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
Identifiers
| code_info | CA090 Direct Drive Clip Applier Lots: 1190181 to 1265006 Kit Lots (containing CA090 Direct Drive Clip Applier recal…CA090 Direct Drive Clip Applier Lots: 1190181 to 1265006 Kit Lots (containing CA090 Direct Drive Clip Applier recalled lot(s)): 1247881 1252438 1255011 1257686 1261514 1263870 1265289 1248696 1254259 1262161 1262467 1241744 1242506 1241942 1242530 1244945 1246374 1247757 1248255 1248753 1251538 1254642 1256360 1265424 1266435 1241831 1242149 1242700 1244651 1244720 1244857 1246492 1246909 1247486 1248756 1251861 1257536 1258435 1261116 1266358 1243272 1234619 1235710 1237695 1238548 1238846 1240793 1244468 1246491 1247651 1247655 1248775 1250498 1250581 1255478 1257218 1258823 1262556 1264157 1238840 1242936 1245022 1245534 1248456 1251192 1252437 1252548 1230056 1235603 1234727 1235922 1237439 1238326 1238403 1238545 1238839 1239478 1240334 1225992 1233274 1235045 1235785 1235914 1237299 1238555 1240591 1249603 1251343 1253126 1255634 1257818 1260397 1263662 1225996 1237442 1237866 1238404 1238477 1238547 1239373 1239475 1239693 1239787 1240084 1252145 1255075 1255630 1256446 12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1621-2016%22
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