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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-2373-2014
Recall Event ID 68536
Product Classification Kit, catheter, foley (excludes hiv testing) - Product Code NWR
Product FOLEY CATHETER KIT 1116FR. - CUSTOM ED-

(1) WRAPPER 24" X 24"
(1) PVP TRIPLE SWABSTICK IODOPHOR
(2) GLOVE MED FREETOUCH VYNIL P/F
(1) JELLY LUBRICATING 5 GRAM
(1) TOWEL 3PLY POLY 17" X 18"
(2) SWABSTICK DRY COTTON
(1) DRAPE 4" FENESTRATED 18" X 26"
(1) CATHETER 16FR. FOLEY, 2 WAY,5cc, Silicone Coated
(1) SYRINGE 10cc WATERPREFIL UF
(1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF
(1) LABEL ID PATIENT
(1) TRAY ORGANIZER
(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 900-1127, 27 lots: 111082044 111092578 111102824 111112983 111123318 112020311 112030602 112041178 112072767 112083205 112093744 113015572 113025906 113036449 113047145 113068141 113088830 113099339 131110626 131210624 140111138 140211532 140211883 140412442 140412828 140513066 140513253 
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; 67410 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.
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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