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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 Customed see related information
Date Initiated by Firm May 20, 2014
Date Posted August 29, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall Number Z-2340-2014
Recall Event ID 68536
Product Classification Drape, surgical - Product Code KKX
Product FANFOLD DRAPE - CUSTOMED
(1) DRAPE SHEET 42" X 57" SMS
(1) WRAPPER 24" X 24"

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-633, 56 lots: 109020284 109040849 109051210 109071550 109092075 109102340 109112583 109122699 110010102 110010242 110020460 110030683 110030781 110041029 110051365 110071704 110082030 110092351 110102554 110102670 110122940 111010146 111020229 111030685 111040913 111051394 111051461 111061682 111061683 111071941 111071967 111082323 111092606 111102772 112041342 112052001 112062213 112062502 112083438 112093948 113036375 113036674 113036735 113047026 113057496 113068177 113078605 113089078 113099293 113109865 131110269 131210834 140211674 140412471 140412797 140513350 
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 2		 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 56 lots; 60820 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.
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