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-2509-2014
• Recall Event ID: 68536
• Product Classification: Orthopedic tray - Product Code OJH
• Product: ORTHOPEDIC IMPLANT ; PACK CUSTOMED USA, CODE 900-2903; CONTENTS:; (1) CAUTERY TIP POLISHER UF ; (1) SKIN MARKER W/RULER; (1) BAG SUTURE FLORAL ; (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21"; (1) TUBE SUCTION CONNECT W' X 12' UF ; (2) PAD ABDOMINAL 8" X 7.5"; (1) BAG GLASSINE ; (1) YANKAUER SUCTION TUBE W/0 VENT LIF; (2) LITE GLOVE UF ; (1) SOLUTION SURGICAL DURAPREP 26ML LIF; (2) TABLE COVER REINFORCED 50" X 90" LIF ; (1) BLADE SURGICAL# 10 STAINLESS STEEL; (1) MAYO STAND COVER REINFORCED LIF ; (1) SHEET SPLIT W/ADHES 108" X 77" STD SMS L/F ; (5) TOWELS ABSORBENT 15" X 20" UF ; (1) STOKINETIE IMPERVIOUS 14" X 48" LIF; (2) DRAPE SHEET 70" X 100" LIF ; (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX ; (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ; (1) *GLOVE # 8 SURGEON NEUTRALON LATEX ; (1) SKIN STAPLE 35 WIDE UF ; (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX; (1) TRAY MAYO LGE ; (1) GOWN SURG REINFORCED XL TOWEUWRAP; (1) DRAPE TOP W/ADHES 108" X 50" STD SMS UF ; (2) GOWN XL SMS IMPERVIOUS REINFORCED UF ; (1) BULB SYRINGE 60cc CLEAR ; (1) CAUTERY PENCYL ROCKER SWITCH UF; (1) UTILITY BOWL 16oz LIF ; (1) BLADE SURGICAL# 20 STAINLESS STEEL ; (1) UTILITY BOWL QUART 32oz LIF ; (4) DRAPE UTILITY WITAPE UF; (1) DRAPE INCISION 23" X 17" UF; ; Product Usage:; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Code 900-2903, 4 lots 113026303 113057705 113068034 113088858
• 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: 4 lots, 180 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.