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U.S. Department of Health and Human Services

Class 1 Device Recall Customed

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 Class 1 Device Recall Customedsee related information
Date Initiated by FirmMay 20, 2014
Date PostedAugust 29, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall NumberZ-2485-2014
Recall Event ID 68536
Product Classification General surgery tray (kit) - Product Code LRO
ProductUniversal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE (1) DRAPE TOP W/ADHESIVE 1 08" X 50" STD SMS (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN SURG. REINFORCED XLGE TOWEL I WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information 900-2509, 3 lots: 112020357 112051971 113078530 
Recalling Firm/
Manufacturer		 Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
For Additional Information ContactRosemari 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 2		Package design/selection
ActionCustomed 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 Commerce3 lots, 612 units, multiple units per pack
DistributionWorldwide 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 CycleTPLC 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.
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