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-2422-2014
• Recall Event ID: 68536
• Product Classification: General surgery tray (kit) - Product Code LRO
• Product: ENDOVENOUS CUSTOM PACK - CUSTOMED; ; (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F; (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF; (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF; (20) GAUZE SPONGE 4" X 4" 12PL Y LIF; (3) GOWN SMS X-LARGE STD NON REINFORCED; ( 1) TABLE COVER 44" X 90"; (4) DRAPE UTILITY WITH TAPE L/F; ( 1) DENTURE CUP WITH LID; ( 1) UTILITY BOWL 16oz.; (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F; (4) RUBBER BAND; ( 1) NEEDLE HYPODERMIC 27G X 1 Y.."; ( 1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF; (3) CAP NURSE 21 " GREEN BOUFFANT; (3) MASK SURGICAL BLUE 120MM HG LIF; ( 1) PREPPING PAD WITH CUFF; (2) TIP ABSORB. APPLIC. STICK SPONGE L/F; ( 1) SCALPEL WEIGHTED SAFETY # 11; ( 1) PROBE DRAPE ST 6" X 96" NO GEL LIF; ( 1) WRAPPER 30" X 30"; (3) TOWELS ABSORBENT 15" X 20" L/F; ; Product Usage:; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-1937, 12 lots: 111082312 111113057 112020431 112051902 112062289 113025829 113026168 113067902 113088773 131210660 140211699 140312423
• 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; 190 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.