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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-2393-2014
Recall Event ID 68536
Product Classification General surgery tray (kit) - Product Code LRO
Product REYITO UROLOGY PACK -
(2) GOWN IMP. REINFORCED X-LARGE SMS
(2) TOWELS ABSORBENT UF
( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF
( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF
( I) BAG SUTURE
(I) TABLE COVER
( I} TUBE SUCTION CONNECT. W' X 12' UF
(10) GAUZE SPONGES 4" X 4" 16PLY
( I) EMESIS BASIN
(I) DRAPE LASER CAMERA W/E
( I} UTILITY BOWL32oz
(I) BOWL PLASTIC 80oz WITH LID
( I) SYRINGE IOcc W/0 NDL. LUER LOCK UF
(I} SYRINGE IOcc PREFILLED WITH GEL
(5) CONTAINER SPECIMEN 4oz W/LID & LABEL
(I) GOWN SURG. REINFORCEDT/WRAP X-LARGE
( I} TUR Y SET, 2LEAD UF
( I} DRAPE LITHO 11 0" X 63" WI POUCH WILEGGING
( I} ROUND WASH BASIN 6QT.

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-1460, 29 lots: 109050945 111123344 112010046 112020337 112041074 112051759 112062229 112062272 112083031 112083391 112093722 112114564 112124948 113015428 113036592 113047001 113047147 113057686 113067887 113078253 113078702 113089190 131110174 131210632 140111081 140211866 140311920 140312391 140513089 
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 29 lots; 1521 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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