If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle.Ī redesigned replacement product will be sent out to consignees within 30-60 days of product return.Įthicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. This may result in: Tubing Strain Relief migrating on the Tubing Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band or a free foreign body in the abdominal wall or abdominal (peritoneal) caĮthicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated Octoto all consignees identifying the affected devices and actions to be taken.ĭO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall.Įxamine inventory and remove the affected product. The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC, ZHLBBD, ZHLBBF, ZHLBBG, ZHLBCM, ZHNBC3, ZHPBBV, ZHPBBY, ZJBBB1, ZJBBB2, ZJBBB3, ZJBBBG, ZJBBBH, ZJBBBK, ZJBBCF, ZJBBCG, ZJBBCH, ZJBBCJ, ZJBBD6, ZJBBD7, ZJBBD8, ZJBBD9, ZJBBDH, ZJBBDJ, ZJBBDK, ZJBBFB, ZJBBFC, ZJCBBT, ZJCBBV, ZJCBBW, ZJCBDL, ZJCBDM, ZJCBDN, ZJDBBL, ZJDBDY, ZJFBBB, ZJFBBC, ZJFBBD, ZJFBDC, ZJFBDD, ZJFBF0, ZJFBF1, ZJFBF2, ZJFBKH, ZJFBMK, ZJGBCC, ZJGBCD, ZJGBGM, ZJGBHJ, ZJGBHK, ZJGBTT, ZJHBCD, ZJHBCF, ZJHBCG, ZJHBF5, ZJHBF6, ZJHBF7, ZJHBK8, ZJHBK9, ZJHBLB, ZJHBLC, ZJHBLD, ZJHBLF, ZJJBC4, ZJJBC5, ZJJBC6, ZJJBF9, ZJJBGB, ZJJBGC, ZJJBHM, ZJJBHN, ZJJBHP, ZJJBHR, ZJJBLK, ZJJBLL, ZJJBNV, ZJJBNW, ZJKBBB, ZJKBBC, ZJKBBD, ZJKBC2, ZJKBC3, ZJKBC4, ZJKBHD, ZJKBK4, ZJKBK5, ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7 & ZLFBFB. REALIZE¿ Adjustable Gastric Band, Injection Port and Applier Implant, intragastric for morbid obesity - Product Code LTI Class 2 Device Recall REALIZE Adjustable Gastric Band, Injection Port and Applier
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