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U.S. Department of Health and Human Services

Class 2 Device Recall FOLEY CATHETER KIT II

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  Class 2 Device Recall FOLEY CATHETER KIT II see related information
Date Initiated by Firm July 10, 2015
Date Posted September 03, 2015
Recall Status1 Terminated 3 on April 12, 2017
Recall Number Z-2566-2015
Recall Event ID 71721
510(K)Number K962652  
Product Classification Kit, catheter, foley (excludes hiv testing) - Product Code NWR
Product FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
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Code Information Code:9001127  Lots: 150115092 exp. 1/31/16 150115092 exp. 1/31/16 150217549 exp. 2/28/16 150317666 exp. 4/30/16 150317666 exp. 4/30/16 150317666 exp. 4/30/16 150317667 exp. 4/30/16 150418282 exp. 4/30/16 150418282 exp. 4/30/16 150418282 exp. 4/30/16 
Recalling Firm/
Manufacturer		 Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
Manufacturer Reason
for Recall		 Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
FDA Determined
Cause 2		 Packaging
Action Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
Quantity in Commerce 1960 kits
Distribution Distributed Only in Puerto Rico.
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.
510(K) Database 510(K)s with Product Code = NWR and Original Applicant = CUSTOMED, INC.
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