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-2367-2014
• Recall Event ID: 68536
• Product Classification: Obstetrical kit - Product Code OKV
• Product: OB PACK -; (1) BABY BLANKET PRINTED; (1) BABY BEANIES; (1) TABLE COVER REINFORCED 50" X 90" LIF; (2) LEGGINS W/7'' CUFF 30" X 42" LIF; (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF; (3) TOWEL ABSORBENT 15" X 20" LIF; (1) DRAPE SHEET 41 " X 58" SMS LIF; (2) PAD OBSTETRICAL X-LARGE LIF; (1) RECEIVING BLANKET 100% COTTON; (1) PVP SCRUB 8" STICK SPONGE; (1) FEEDING TUBE BFR, 15" LONG LIF; (1) BOWL PLASTIC 80oz WITH LID; (1) CORD UMBILICAL CLAMP; (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF; (1) SYRINGE 20cc SLIP TIP LIF; (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF; (1) NEEDLE HYPODERMIC 18G X 1%; (1) NEEDLE HYPODERMIC 22G X 1%; (20) GAUZE SPONGE 4" X 4" 16PL Y; (1) EAR ULCER SYRINGE 2oz LIF; (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" LIF; (2) GLOVE MED FREETOUCH VYNIL POWDER FREE; (1) WRAPPER 24" X 24" L/F; (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP LIF; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-1030, 18 lots: 112041230 112072809 112093846 112104130 112114918 113026212 113036313 113047310 113057379 113067853 113078668 113109703 131110148 131210674 140111136 140211630 140311913 140513060
• 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: 18 lots; 1580 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.