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-2327-2014
• Recall Event ID: 68536
• Product Classification: laparoscopy kit - Product Code FDE
• Product: LAPAROSCOPY PACK- -; (1) DRAPE LAP ABDOMINAL WITH POUCH; (1) CAMARA DRAPE 9" X 96" LIF; (5) TOWELS ABSORBENT 15" X 20"; (1) MAYO STAND COVER REINFORCED; (1) TABLE COVER REINFORCED 50" X 90"; (4) DRAPE UTILITY WITH TAPE; (3) DRAPE SHEET 41" X 58" SMS; (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR; (5) LAP SPONGE PREWASH 18" X 18" XRD; (1) GOWN LGE SMS IMPERVIOUS REINFORCED; (2) GOWN X-LARGE SMS IMPERV. REINFORCED; (2) MEDICINE CUP 2oz.; (1) NEEDLE HYPODERMIC 18G X 1% ST.; ( 1) BLADE SURG. # 15 CARBON STEEL; (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK; (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR; (1) DRESSING TEGADERM 4" X 4%"; (1) SOLUTION SURGICAL DURAPREP 6mL; (1) TRAY MAYO SMALL; (1) TUBE SUCTION CONNECT. %"X 12'; (10) GAUZE SPONGE 4" X 4" 16PLY XRD; (1) NEEDLE ECLIPSE 22 X 1%; (1) TIME OUT BEACON NON WOVEN ST; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
• Code Information: Product code 900-474, 19 lots: 112030843 112103944 112114393 112114480 112125096 113015452 113036801 113057847 113078330 113088867 113089075 113109844 131110262 131210818 140111232 140211671 140412469 140412888 140513480
• 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: 19 lots; 1168 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.