Recall Z-1621-2016
Applied Medical Resources Corp · initiated April 1, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 1257220 1258017 1258726 1260294 1261907 1263948 1226411 1236219 1241391 1242529 1243974 1244946 1248224 1226407 1235931 1237674 1242254 1243047 1243791 1243891 1249850 1256895 1259667 1259851 1219268…
Reason for recall
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
FDA-determined cause: Nonconforming Material/Component
Action taken
Customer notification letters were sent on 04/01/16 via UPS. The notification requests that customers check their inventory for recalled products, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if the facility is returing or has already used any of the products. If customers are a distributor it is requested that they notify any facilities to which have been distributed the affected product. Customers are asked to return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60698158@appliedmedical.com or faxing to (949) 713-8921. Customers are to return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical. For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at lcontursi@appliedmedical.com.
Details
- Recall number
- Z-1621-2016
- Initiated
- April 1, 2016
- Posted by FDA
- May 6, 2016
- Terminated
- February 7, 2017
- Product code
- FZP – Clip, Implantable
- Quantity
- 559,274
- Distribution
- U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico…
- Recalling firm
- Applied Medical Resources Corp, Rancho Santa Margarita, CA