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-2354-2014
• Recall Event ID: 68536
• Product Classification: Cesarean section kit - Product Code OHM
• Product: CESAREAN PACK- ; (1) BEANNIES BABY LIF; (1) TABLE COVER REINFORCED 50" X 90" LIF; (1) COVER MAYO STAND REINFORCED LIF; (3) SHEET DRAPE 41 " X 58" SMS LIF; (5) TOWEL ABSORBENT 15" X 20" LIF; (15) SPONGE LAP PREWASH 18" X 18" XRD LIF; (1) YANKAUER SUCTION TUBE W/0 VENT L/F; (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF; (2) PAD OBSTETRICAL X-LARGE LIF; (1) SYRINGE EAR/ULCER 2oz. L/F; (1) BLANKET BABY PRINTED; (1) TUBE SUCTION CONNECT Y-1" X 12' LIF; (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF; (1) BLANKET RECEIVING 100% COTTON; (1) BOWL W/LID PLASTIC 80oz.; (1) UMBILICAL CORD CLAMP; (1) TUBE FEEDING PVC 8FR 15" LONG; (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF; (1) BAG SUTURE FLORAL; (2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE; (1) SCALPEL W/HANDLE #1 0; (1) SCALPEL W/HANDLE #20; (2) BOWL UTILITY 16oz. LIF; (1) PVP PAINT 8" STICK SPONGE LIF; (1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF; (1) PENCIL CAUTERY HAND SWITCHING LIF; (1) SCISSOR UMBILICAL 4.5" STRAIGHT; (1) WRAPPER 24" X 24" LIF; (1) PVP SCRUB 8" STICK SPONGE LIF; (1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF; (1) TIME OUT BEACON NON WOVEN LIF; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-851, 19 lots: 112093954 112114401 112125118 113015517 113046987 113047162 113057510 113067939 113078349 113088895 113099457 113109877 131110317 140111098 140211857 140312187 140412474 140513147 140513483
• 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; 968 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.