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-2364-2014
• Recall Event ID: 68536
• Product Classification: Ring, laparotomy - Product Code FHI
• Product: LAPAROTOMY PACK- ; ; (1) MAYO STAND COVER REINFORCED LIF; (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF; (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF; (1) LITE GLOVE LIF; (1) BAG SUTURE FLORAL; (1) BLADE SURGICAL #1 0 CARBON STEEL; (1) BLADE SURGICAL #15 CARBON STEEL; (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF; (1) CAUTERY TIP POLISHER LIF; (1) BAG GLASSINE; (1) TABLE COVER 44" X 90" L/F; (2) DRAPE SHEET 41 " X 58" SMS; (1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS; (4) DRAPE UTILITY WITH TAPE LIF; (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF; (1) TUBE SUCTION CONECT W' X 12' LIF; (3) ABSORBENT TOWELS 15" X 20" LIF; (1) CAUTERY PENCIL PUSH BOTTON; (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill; (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-996, 34 lots: 111040982 111051305 111061694 111071947 111082120 111092410 111092465 111102789 111113147 111123308 112010213 112020496 112030757 112041365 112052027 112072880 112083444 112093958 112114585 112125124 113025974 113036393 113057517 113057612 113057822 113078480 113078577 113099300 113099581 131110081 131110607 140111262 140211738 140513485
• 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: 34 lots; 3603 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.