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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-2400-2014
Recall Event ID 68536
Product Classification General surgery tray (kit) - Product Code LRO
Product UROLOGY PACK-
(10) GAUZE SPONGE 4" X 4" 16PLY
(1) TUBE SUCTION CONNECT Y." X12'
(1) SYRINGE 30cc WITHOUT NEEDLE ULOCK
(1) BASIN RING
(1) TUR Y SET, 2 LEAD, ST.
(1) BAG SUTURE FLORAL
(1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV
(2) TOWEL CLAMP
(1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS
(1) COVER TABLE REINF 50" X 90"
(1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX
(3) TOWELS ABSORBENT 15" X 20"
(1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV
(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL
(1) TIME OUT BEACON NON WOVEN ST.

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-1521, 27 lots: 111102904 112041376 112041452 112062286 112104149 112114602 112124957 113015430 113015690 113025942 113026048 113036739 113046934 113047002 113047332 113057836 113078260 113088737 113088931 113089193 131110180 131110598 131210962 140211645 140211922 140412884 140513346 
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 27 lots; 1884 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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