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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-2374-2014
Recall Event ID 68536
Product Classification Kit, catheter, foley (excludes hiv testing) - Product Code NWR
Product FOLEY CATHETER KIT 1118FR.- CUSTOM ED
CONTENTS:
(1) WRAPPER 24" X 24"
(1) LABEL ID PATIENT
(1) TRAY ORGANIZER
(1) PVP TRIPLE SWABSTICK IODOPHOR
(2) GLOVE MED FREETOUCH VYNIL P/F
(1) JELLY LUBRICATING 5 GRAM
(1) TOWEL 3PL Y POLY 17" X 18"
(2) SWABSTICK DRY COTTON
(1) DRAPE 4" FENESTRATED 18" X 26"
(1) CATHETER FOLEY 18FR, 2WAY SILICONE COATED
m SYRINGE 10ccWATERPREFIL UF
(1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF
(1)SPECIMEN CONTAINER 4oz W/LID & LABEL


EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-1139, 13 lots: 111112985 111123474 112010023 112041179 112072768 112083208 112093742 112103742 112114377 113015573 113109708 140211533 140412580 
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 13 lots; 12820 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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