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-2323-2014
• Recall Event ID: 68536
• Product Classification: laparoscopy kit - Product Code FDE
• Product: LAPAROSCOPY CHOLE PACK - -; ( 1) STRIP STERI CLOSURE W' X 4" LIF; ( 1) TABLE COVER REINFORCED 50" X 90" LIF; ( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF; (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF; ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F; (5) TOWELS ABSORBENT 15" X 20" LIF; (5) LAP SPONGE PREWASH 18" X 18" XRD LIF; (4) DRAPE UTILITY WIT APE LIF; ( 1) COVER CAMERA W/ELAST LIF; (2) GAUZE SPONGE 4" X 4" 12PL Y LIF; ( 1) NEEDLE ULTRA VERES 120mm LIF; (2) DRAPE SHEET 41 " X 58" SMS LIF; ( 1) SCALPEL WEIGHTED SAFETY #11; ( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF; ( 1) DRESSING TEGADERM 4" X 4 %" LIF; ( 1) TUBE SUCTION CONNECT X" X 12' LIF; ( 1) MAYO STAND COVER REINFORCED LIF; ( 1) SUTURE BAG FLORAL LIF; ( 1) Pk. STERI STRIP LAP SET LATEX; ( 1) CORD LAPAROSCOPY MONOPOLAR LIF; ( 1) MAYO TRAY SMALL LIF; ( 1) TIME OUT BEACON NON WOVEN ST. LIF; (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF; ( 1) BAG ZIP LOCK PLASTIC 6" X 10"; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
• Code Information: Product code 900-414, 26 lots: 112030868 112041328 112051656 112062284 112072802 112093940 112104108 112114600 113015696 113025963 113036361 113036800 113057485 113068047 113068170 113088863 113089072 113099574 131110261 131210813 140111100 140211669 140311938 140412466 140412887 140513363
• 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: 26 lots; 2192 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.