Class 1 Device Recall Customed

• Date Initiated by Firm: May 20, 2014
• Date Posted: August 29, 2014
• Recall Status: Terminated on August 14, 2017
• Recall Number: Z-2423-2014
• Recall Event ID: 68536
• Product Classification: General surgery tray (kit) - Product Code LRO
• Product: HIGADO & PANCREA PACK - ; (1) BAG SUTURE FLORAL ; (2) YANKAUER SUCTION TUBE WITHOUT VENT; (4) DRAPE UTILITY WITH TAPE ; (6) TOWELS CLOTH HUCK BLUE; (1) SHEET DRAPE 41 " X 58" SMS ; (1) MAYO TRAY LARGE; (1) TABLE COVER REINFORCED 50" X 90" ; (1) DRAPE INCISE ANTIMICROBIAL 23" X 17"; (1) DRAPE BARIATRIC ; (1) BLADE SURGICAL #10 STAINLESS STEEL; (1) CUP SPECIMEN WITH CAP 4oz ; (1) BLADE SURGICAL #15 STAINLESS STEEL; (30) LAP SPONGE PREWASH 18" X 18" XRD ; (1) STRIP STERI CLOSURE W X 4"; (1) POLISHER CAUTERY TIP ; (1) NEEDLE ECLIPSE 22 X 1 Y2; (4) TOWEL ABSORBENT 15" X 20" ; (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK; (2) LITE GLOVE ; (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER; (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR ; (1) FORCE TRIVERSE; (1) SYRINGE BULB 60CC ; (1) BLADE EXTENDED ELECT. 16.51cm; (2) TUBE SUCTION CONNECT Y." X 12' ; (2) CHLORAPREP 26ML APPLICATOR TEAL; (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE; ; Product Usage:; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-1966, 18 lots: 113025951 113026188 113036672 113047210 113067907 113078582 113099405 113109642 113109776 131110111 131110333 131210639 140111088 140211806 140312102 140412625 140412892 140513119
• Recalling Firm/ Manufacturer: Customed, Inc; Calle Igualdad Final #7; Fajardo PR 00738
• For Additional Information Contact: Rosemari Melendez; 787-622-5151 Ext. 7540
• Manufacturer Reason for Recall: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
• FDA Determined Cause: Package design/selection
• Action: Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
• Quantity in Commerce: 18 lots; 738 units (multiple units per lot)
• Distribution: Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.