Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LAPAROTOMY PACK

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall LAPAROTOMY 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-2610-2015
Recall Event ID 71721
510(K)Number K902031  
Product Classification General surgery tray (kit) - Product Code LRO
Product LAPAROTOMY PACK CUSTOMED 7/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:900176 Lots: 141216310 exp. 12/31/15 150116977 exp. 1/31/16 150116977 exp. 1/31/16 150116775 exp. 1/31/16 150116772 exp. 1/31/16 150116774 exp. 1/31/16 150116773 exp. 1/31/16 150317694 exp. 3/31/16 150317695 exp. 3/31/16 150317696 exp. 3/31/16 150317697 exp. 3/31/16 150317698 exp. 3/31/16 150317693 exp. 3/31/16 150418316 exp. 4/30/16 150418317 exp. 4/30/16 150418578 exp. 4/30/16 150418579 exp. 4/30/16 150519009 exp. 5/31/16 150619364 exp. 6/30/16 150619365 exp. 6/30/16 150619366 exp. 6/30/16 150619367 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 2142
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.
-
-