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-2430-2014
• Recall Event ID: 68536
• Product Classification: Cesarean section kit - Product Code OHM
• Product: CESAREAN PACK - ; (1) BABY BLANKET IMP. POLY ABS. ; (4) ABSORBENT TOWELS 15" x 20" LIF; (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF ; (2) LITE GLOVES LIF; (1) BOWL PLASTIC WITH LID 80 oz. ; (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78"; (1) UTILITY BOWL 32 oz. ; (10) LAP SPONGES PRE-WASHED XRD LIF; (2) PAD OBSTETRICAL XLGE ; (1) BABY BEANNIES; (1) MAYO STAND COVER REINFORCED L/F ; (1) DRAPE SHEET 41" X 58" SMS LIF; (1) TUBE SUCTION CONNECT. X" X 12' L/F ; (1) EAR ULCER SYRINGE 2oz. LIF; (1) RECEIVING BLANKET 100% COTION ; (1) YANKAUER SUCT TUBE WITHOUT VENT L/F; (1) UMBILICAL CORD CLAMP ; (2) WRAPPER 20"X 20"; (1) DRESSING ISLAND 4" X 10" ; (1) SCALPEL# 10 WITH HANDLE S/S; (1) SCALPEL# 20 WITH HANDLE ; (1) TABLE COVER REINFORCED 50" X 90" L/F; (1) MAYO TRAY SMALL ; (1) MUCUSTRAP 20cc 1 OFr.; (2) GOWN LGE SMS IMPERVIOUS REINFORCED ; (1) SURGICAL DURAPREP SOLUTION 26mL L/F; ; Product Usage:; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-2005, 14 lots: 111123199 112030704 112041279 112051918 112083420 112125056 113036459 113047202 113057860 113078296 113088780 113109780 140211726 140412462
• 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 differ 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: 14 lots; 420 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.