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-2322-2014
• Recall Event ID: 68536
• Product Classification: Cesarean section kit - Product Code OHM
• Product: CESAREAN PACK - - ; (1) MAYO STAND COVER REINFORCED LIF; (20) LAP SPONGES PRE-WASH XRD LIF; (1) UMBILICAL CORD CLAMP LIF; (1) COVER TABLE REINFORCED 50" X 90" LIF; (1) SURGICAL DURAPREP SOLUTION 26ML LIF; (1) BEANNIES BABY; (1) POLISHER TIP CAUTERY LIF; (1) LITE GLOVE L/F; (1) CAUTERY PENCIL ROCKER SWITCH L/F; (1) C-SECTION DRAPE WITH POUCH LIF; (1) MAYO TRAY SMALL; (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F; (1) BLADE SURGICAL #10 CARBON STEEL; (2) BOWL UTILITY 32oz. LIF; (2) PAD OBSTETRICAL X- LARGE LIF; (5) TOWEL ABSORBENT 15" X 20" LIF; (1) DRAPE SHEET 41" X 58" SMS LIF; (1) TUBE SUCTION CONNECT. Y.." X 12' LIF; (1) EAR ULCER SYRINGE 2oz. LIF; (2) GOWM IMPERVIOUS EXTRA REINFORCED X-LARGE; (1) RECEIVING BLANKET 100% COTTON; (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR LIF; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
• Code Information: Product code 900-410, 24 lots: 112020166 112020534 112030841 112041322 112051983 112062488 112072871 112083430 112093939 112114673 112125090 113025992 113036358 113036764 113078476 113078814 113099291 113099573 131110300 140111223 140211668 140312159 140412838 140513349
• 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: 24 lots; 2564 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.