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-2394-2014
• Recall Event ID: 68536
• Product Classification: Orthopedic tray - Product Code OJH
• Product: IMPLANTE DE ORTHOPEDIA - ; ( I) CAUTERY T IP POLI SHER LIF ; ( I) BAG SUTURE FLORAL LIF; ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ; ( I) BAG GLASSINE LIF; (2) LITE GLOVE LIF ; (2) TABLE COVER 50" X 90" REINFORCED LIF; ( I) MAYO STAND COVER REINFORCED LIF ; (5) TOWEL ABSORBENT 15" X 20" LIF; (4) DRAPE UTILITY WITH TAPE LIF ; (2) DRAPE SHEET 70" X I 00" LIF; (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F ; ( I) MAYO TRAY LARGE LIF; ( I) DRAPE TOP WITH ADHESIVE LIF ; ( I) SKIN STAPLE 35 WIDE LIF; ( I) BULB SYRINGE 60cc LIF ; ( I) UTILITY BOWL 16oz L/F; (2) UTILITY BOWL 32oz L/F ; ( I) INCISION DRAPE 23" X I 7" L/F; (I) SKIN MARKER WITH RULER LIF ; ( I) U-DRAPE 54" X 72" W/TAPE SPLIT 6" X 2 1" LIF; (2) ABDOMINAL PAD 8" X 7.5" L/F ; ( I) YANKAUER SUCTION TUBE W/0 VENT L/F; (I) DURAPREP SURGICAL SOLUTION 26ML LIF ; ( I) SURGICAL BLADE # 10 STAINLESS STEEL; (I) SPLIT SHEET W/ADH 108" X 77"" STD SMS LIF ; ( I) IMP. STOCKINETTE LIF; (I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX ; ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX; (I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX ; (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF; (2) IMP. GOWN REINFORCED X-LARGE SMS LIF ; (I) PENCIL CAUTERY ROCKER SWITCH LIF; (I) SURGICAL BLADE #20 STAINLESS STEEL; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-1476, 12 lots: 112030618 112072885 112104097 112114378 112114555 112124949 113015689 113047329 113078255 113088832 113089191 121104357
• 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: 12 lots; 399 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.