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U.S. Department of Health and Human Services

Class 2 Device Recall CESAREAN PACK

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  Class 2 Device Recall CESAREAN PACK 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-2672-2015
Recall Event ID 71721
Product Classification Cesarean section kit - Product Code OHM
Product CESAREAN PACK 3/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:900403 Lots: 141015707 exp. 10/31/15 141216329 exp. 12/31/15 150116529 exp. 1/31/16 150116530 exp. 1/31/16 150116531 exp. 1/31/16 150116532 exp. 1/31/16 150317799 exp. 3/3/16 150317800 exp. 3/31/16 150317801 exp. 3/31/16 150317802 exp. 4/30/16 150418395 exp. 4/30/16 150418394 exp. 4/30/16 150418396 exp. 4/30/16 150518580 exp. 5/31/16 150518581 exp. 5/31/16 
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 507
Distribution Distributed Only in Puerto Rico.
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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