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-2387-2014
• Recall Event ID: 68536
• Product Classification: Neurological tray - Product Code OJG
• Product: NEURO SPINE PACK - ; (1) BAG SUTURE FLORAL ; (1) COVER TABLE 44" X 90"; (4) ABSORBENT TOWELS 15" X 20" UF ; (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS; (4) DRAPE UTILITY WITH TAPE LIF ; (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP; (1) DURAPREP SURGICAL SOLUTION 26mL UF ; (1) INCISION DRAPE 23" x 17"; (1) INSTRUMENT POUCH ; (2) CAUTERY TIP POLISHER LIF; (1) CAUTERY PENCIL HANDSWITCHING LIF ; (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL; (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF ; (2) LITE GLOVES LIF; (1) TUBE SUCTION CONNECT. Y.." X 12' LIF ; (1) SKIN MARKER WITH RULER; (1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF ; (1) Pk SURGICAL STRIP W'X 6"; (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F ; (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF; (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL ; (5) DRAPE % ECONOMY 53" X 77" LIF; (2) TABLE COVER HD 77" X 110" L!F ; (1) MAYO TRAY LARGE; (1) UTILITY BOWL 16 oz LIF ; (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F; (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF ; (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL; (1) J VAC RESERVOIR 300 mL; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-1300, 20 lots: 109050993 112051747 112093868 112104141 112124943 113015633 113025937 113036226 113046883 113047325 113057419 113078249 113099270 113109990 131110171 140111097 140211640 140312065 140412551 140513082
• 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: 20 lots; 800 units (multiple lots per unit)
• 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.