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-2356-2014
• Recall Event ID: 68536
• Product Classification: Accessories, operating-room, table (kit) - Product Code FWZ
• Product: ARTHROSCOPY PACK- ; (2) ABSORBENT TOWELS 15" x 20" LIF; (1) TUBE SUCTION CONNECT Y.." X 12' LIF; (1) ELASTIC BANDAGE 6" X 5yrd. UF; (1) IMPERVIOUS STOCKINETTE 14" X 48"; (1) HUCK CLOTH TOWEL WHITE; (1) MAYO STAND COVER REINFORCED LIF; (1) U DRAPE 60" X70" WITH TAPE SPLIT; (4) STRIPS TAPE 24" X 4" L/F; (1) STOCKINETTE 6" X 48" LIF; (1) MAYO TRAY SMALL; (5) HUCK CLOTH TOWELS BLUE; (2) UTILITY BOWL 32oz; (2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV; (1) SOLUTION SURGICAL DURAPREP 26ml UF; (1) SHEET EXTREMITY ABS. 125" x 85" SMS; (5) LAP SPONGE PREWASH XRD; (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF; (1) PENCIL CAUTERY ROCKER SWITCH; (1) SKIN MARKER INK WITH 8 LABEL; (2) LITES GLOVES UF; (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR; (1) CAUTERY TIP POLISHER UF; (4) DRAPE UTILITY WITH TAPE UF; (1) BAG BIOHAZARD 30" X 37"; (1) BAG SUTURE FLORAL; (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF; (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP; ; EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
• Code Information: Product code 900-902, 11 lots: 112041360 112051755 112052021 113015521 113025983 113036389 113067942 113078352 140312189 140412917 140513342
• 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: 11 lots; 273 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.