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-2358-2014
• Recall Event ID: 68536
• Product Classification: General surgery tray (kit) - Product Code LRO
• Product: PLASTIC SURGERY PACK- ; (1) MAYO STAND COVER REINFORCED LIF; (1) CAUTERY TIP POLISHER LIF; (1) BAG SUTURE FLORAL L/F; (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF; (20) GAUZE SPONGES 4" X 4" 4PL Y; (1) COVER TABLE REINFORCED 50" X 90" LIF; (2) GOWN IMPERVIOUS REINFORCED LARGE SMS; (1) PENCIL CAUTERY HANDSWITCHING L/F; (1) TUBE SUCTION CONNECT. ~, X 12' LIF; (1 0) LAP SPONGE PRE-WASH XRD LIF; (2) LITE GLOVE LIF; (4) HUCK CLOTH TOWEL BLUE; (2) DRAPE SHEET MEDIUM 41" X 69" LIF; (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF; (1) DRAPE LAP ABDOMINAL WITH POUCH STD SMS; (5) Pk. STERI STRIP CLOSURE %"X 4" L/F; (1) MAGNETIC INST. DRAPE; (3) SKIN MARKER WITH RULER LIF; (1) EXTENDED ELECTRODE BLADE; (2) ABSORBENT TOWEL 15" X 20" LIF; (4) UTILITY BOWL 32 oz; (2) SURGEON GLOVES #8 BIOGEL; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-920, 21 lots: 111051217 111092406 112030888 112052022 112093734 112114584 112125309 113015700 113036806 113057750 113078593 113089210 113099376 113099582 131010028 131110283 140111258 140211862 140312427 140412918 140513470
• 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: 21 lots; 680 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.