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U.S. Department of Health and Human Services

Class 2 Device Recall MAJOR LAP PACK

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  Class 2 Device Recall MAJOR LAP 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-2673-2015
Recall Event ID 71721
510(K)Number K902031  
Product Classification General surgery tray (kit) - Product Code LRO
Product MAJOR LAP PACK 4/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:900404 Lots: 140915488 exp. 10/31/15 141216330 exp. 12/31/15 141216438 exp. 12/31/15 141216438 exp. 12/31/15 150116533 exp. 2/28/16 150116807 exp. 2/28/16 150116808 exp. 2/28/16 150116809 exp. 2/28/16 150116810 exp. 2/28/16 150116811 exp. 2/28/16 150217401 exp. 2/28/16 150217402 exp. 2/28/16 150217404 exp. 2/28/16 150217405 exp. 2/28/16 150217403 exp. 2/28/16 150217406 exp. 2/28/16 150217407 exp. 2/28/16 150217408 exp. 2/28/16 150217409 exp. 2/28/16 150317803 exp. 3/31/16 150317805 exp. 3/31/16 150317808 exp. 3/31/16 150317807 exp. 3/31/16 150317809 exp. 3/31/16 150317806 exp. 3/31/16 150418397 exp. 4/30/16 150418398 exp. 4/30/16 150418399 exp. 4/30/16 150418400 exp. 4/30/16 150418499 exp. 4/30/16 150418500 exp. 4/30/16 150418501 exp. 4/30/16 150418498 exp. 4/30/16 150519002 exp. 5/31/16 150519004 exp. 6/30/16 150519003 exp. 6/30/16 150519005 exp. 6/30/16 150619464 exp. 6/30/16 150619463 exp. 6/30/16 150619385 exp. 6/30/16 150619466 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
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 2736
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.
510(K) Database 510(K)s with Product Code = LRO and Original Applicant = CUSTOMED, INC.
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