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-2378-2014
• Recall Event ID: 68536
• Product Classification: Gynecological laparoscopic kit - Product Code OHD
• Product: LAPAROSCOPY OB GYN PACK - ; (1) DURAPREP SURGICAL SOLUTION 26ML LIF; (1) SHEET T LAPAROSCOPY SMS LIF; (2) DRAPE UTILITY WITH TAPE LIF; (1) DRAPE SHEET 41" X 58" SMS LIF; (4) ABSORBENT TOWELS 15" x 20" LIF; (1) PVP TRIPLE SWABSTICK IODOPHOR; (1) DRAPE LASER CAMERA W/EL 6" X 96"; (1) TUBE SUCTION CONNECT.%" X 12' LIF; (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF; (1) SURGICAL BLADE #11 CARBON STEEL; (1) TABLE COVER 44" X 78" REINFORCED LIF; (1) TEGADERM TRANS DRESSING 6" X 8"; (2) LEGGINS WITH 7" CUFF 30" X 42"; (10) GAUZE SPONGES 4" X 4" 12PLY XRD; (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX; (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF; (1) TUR CYSTO IRRIGATION SET 79"; (1) FOLEY CATHETER 16FR 2WAY, 5CC; (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF; (2) GOWN IMPERVIOUS EXTRA REINF XLG LIF; (1) TROCAR ENDO. XCEL DILATING TIP 5MM (K5LT); (1) PNEUMO INSUFLAT NEEDLE 150MM LUER LOCK LIF; (1) CEFAZOLIN RED LABEL; (1) GENTAMICIN GREEN LABEL; (1) AZUL DE METILENO LABEL; (1) HEPARINE WHITE LABEL; (1) LIDOCAINE YELLOW LABEL; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-1192, 10 lots: 113057752 113067947 113078458 113078680 113099381 140211710 140312054 140412584 140513072 140513334
• 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: 10 lots; 345 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.