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 MINOR 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 MINOR PACKsee related information
Date Initiated by FirmJuly 10, 2015
Date PostedSeptember 03, 2015
Recall Status1 Terminated 3 on April 12, 2017
Recall NumberZ-2638-2015
Recall Event ID 71721
Product Classification General surgery tray (kit) - Product Code LRO
ProductMINOR PACK 4/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:9002511 Lots: 140412903 exp. 5/31/16 140915507 exp. 10/31/15 141216305 exp. 12/31/15 150116550 exp. 1/31/16 150116549 exp. 1/31/16 150116552 exp. 1/31/16 150116551 exp. 1/31/16 150317840 exp. 4/30/16 150317839 exp. 4/30/16 150317841 exp. 4/30/16 150317841 exp. 4/30/16 150317842 exp. 4/30/16 150317843 exp. 4/30/16 150317844 exp. 4/30/16 150418372 exp. 4/30/16 150418373 exp. 4/30/16 150418374 exp. 4/30/16 150418375 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
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 Commerce1452
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.
-
-