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-2379-2014
• Recall Event ID: 68536
• Product Classification: Orthopedic tray - Product Code OJH
• Product: LAMINECTOMY PACK -; ( I) RING BASIN LIF ; (2) TABLE COVER REINFORCED 50" X 90" LIF; ( I) SKIN MARKER INK W/8 LABEL ; ( I) CAUTERY TIP POLISHER LIF; ( I) TUBE SUCTION CONNECT. W' X 12' LIF ; (6) DRAPE UTILITY W/TAPE LIF; (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF ; (2) UTILITY BOWL 16oz. LIF; ( IO) LAP SPONGE PRE-WASH XRD LIF ; (2) SPECIMEN CONTAINER 4oz W/LID & LABEL; (2) MAYO STAND COVER REINFORCED LIF ; ( I) GOWN SURG. REINF. XL TOWEL WRAP; (6) ABSORBENT TOWEL I5" X 20" LIF ; ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF; ( I) SURGICAL DURAPREP SOLUTION 26ML LIF ; (6) DRAPE SHEET 41" X 69" MEDIUM LIF; (2) LEGGING W/7'' CUFF 30" X 42" LIF ; (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR; ( I) CAUTERY PENCIL PUSH BOTTOM LIF ; ( I) BAG SUTURE FLORAL LIF; ( I) PVP SCRUB 8" STICK SPONGE ; ( I) MAYO TRAY LARGE LIF; (I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF ; ( I) SURGICAL BLADE# I 0 CARBON STEEL; (2) BULB SYRINGE 60cc CLEAR LIF ; ( I) SURGICAL BLADE# I I CARBON STEEL; ( I) SURGICAL BLADE # 15 CARBON STEEL ; ( I) GOWN FABRIC REINFORCED SONTARA XL LIF; ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF; ( I) PVP PAINT 8" STICK SPONGE; ( I) SURGICAL STRIP W' X 6" COTTON ; (2) LITE GLOVES LIF; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-1202, 12 lots: 112051738 113078681 113099269 113109712 131110160 131210629 140111078 140211462 140211633 140311918 140412586 140513335
• 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: 12 lots; 450 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.