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-2404-2014
• Recall Event ID: 68536
• Product Classification: laparoscopy kit - Product Code FDE
• Product: LAPAROSCOPY CHOLE PACK - ; (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF; (2) SHEET DRAPE 42" X 57" SMS; (1) TUBE SUCTION CONNECT. %" X12' LIF; (1) SURGICAL BLADE #10 STAINLESS STEEL; (1) TABLE COVER REINFORCED 44" X 78" LIF; (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUCH; (5) LAP SPONGES PREWASH XRD L/F; (1) NEEDLE HYPODERMIC 18G X 1 %"; (1) MAYO STAND COVER REINFORCED LIF; (1) UTILITY BOWL 32oz. L/F; (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF; (4) TOWEL ABSORBENT 15" X 20" L/F; (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL; (1) CLOTH HUCK TOWEL BLUE L/F; (1) PVP PAINT 8" STICK SPONGE; (4) DRAPE UTILITY WITH TAPE LIF; (2) UTILITY BOWL 16oz LIF; (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF; (1) PVP SCRUB 8" STICK SPONGES; (1) CLIPS LIGATING TIT M/L (L T 300); (4) TEGADERM 2 3/8 X 2% L/F; (4) GOWN SURG. REINFORCED LARGE TOWEL/WRAP; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-1688, 16 lots: 112114380 112114643 113036740 113047004 113057426 113068154 113088751 113099276 131110193 140211464 140211704 140311926 140312434 140412555 140513103 140513462
• 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: 16 lots; 843 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.