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-2511-2014
• Recall Event ID: 68536
• Product Classification: Neurological tray - Product Code OJG
• Product: ACDFPACK; SURGICAL CENTER, CODE 900-2917.; CONTENTS:; ; (1) SOLUTION SURGICAL DURAPREP 6ML LIF; (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF; (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF ; (3) TOWELS ABSORBEN 15" X 20" UF; (1) TABLE COVER REINFORCED 50" X 90" L/F ; (1) MAYO STAND COVER REINFORCED LIF; (2) DRAPE o/.. 60" X 76" REINFORCED LIF ; (1)DRAPE THYROID 100" X 142" X 72" LIF; (1) FLUORO COVER 30" X 30" W/RUBBAND L/F ; (1) DRAPE INCISE IOBAN 13" X 13"; (2) LITE GLOVE LIF; (2) TUBE SUCTION CONNECT. W X 12' LIF ; (12) TOWELS CLOTH HUCK BLUE LIF; (1) UTILITY BOWL 16oz LIF; (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF; (5) LAP SPONGE PREWASH 18" X 18" XRD LIF; (1) SKIN MARKER W/RULER LIF; (9) LABELS FOR SKIN MARKERS 1.25 X Y:! ; (1) RULER; (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF; (2) SYRINGE 20cc W/0 NDL LUER LOCK LIF ; (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF ; (1) BULB SYRINGE 60cc LIF; (3) NEEDLE HYPODERMIC 18G X 1Y:! LIF ; (1) NEEDLE 30G X 1 DISP. L/F; (1) NEEDLE SPINAL ANESTH 18G X 3W' LIF ; (2) BLADE SURGICAL# 15 CARBON STEEL ; (1) TIME OUT BEACON NON WOVEN LIF; (2) TAPE TEGADERM 2 3/8 "X 2 o/.. "L/F; (2) MEDICINE CUP 2oz LIF; Product Usage:; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Code 900-2917, 6 lots 113047022 113057702 113068036 113078732 113109798 140312146
• 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: 6 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.