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U.S. Department of Health and Human Services

Class 2 Device Recall MINOR LAPAROTOMY

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 Class 2 Device Recall MINOR LAPAROTOMYsee related information
Date Initiated by FirmJuly 10, 2015
Date PostedSeptember 03, 2015
Recall Status1 Terminated 3 on April 12, 2017
Recall NumberZ-2679-2015
Recall Event ID 71721
510(K)NumberK902030 
Product Classification General surgery tray (kit) - Product Code LRO
ProductMINOR LAPAROTOMY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Code Information Code:900450 Lots: 141015752 exp. 11/30/15 141216340 exp. 12/31/15 150217416 exp. 2/28/16 150217417 exp. 2/28/16 150217418 exp. 2/28/16 150217419 exp. 2/28/16 150317988 exp. 3/31/16 150317987 exp. 3/31/16 150317985 exp. 3/31/16 150317986 exp. 3/31/16 150418502 exp. 4/30/16 150619371 exp. 6/30/16 
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
ActionCustomed 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 Commerce675
DistributionDistributed Only in Puerto Rico.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LRO
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