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 1 Device Recall Tracheotomy Care Kit

  • 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 1 Device Recall Tracheotomy Care Kitsee related information
Date Initiated by FirmOctober 08, 2014
Date PostedDecember 16, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall NumberZ-0242-2015
Recall Event ID 69448
Product Classification Kit, tracheotomy care - Product Code NXA
ProductTracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Code Information Lot numbers:  111102823 111112980 111123314 111123440 112020308 112020361 112030826 112041369 112041434 112051646 112062317 112083160 112093741 112104363 112124894 113015487 113035832 113046996 113047144 113057604 113057810 113078456 113078674 113089014 113109706 131110154 131110288 131210677 140111108 140211531 140312046 140412578 140513065 140613570 140714155 140714430 140814942 
Recalling Firm/
Manufacturer		 Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
For Additional Information Contact
787-622-5151
Manufacturer Reason
for Recall		Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
FDA Determined
Cause 2		Packaging
ActionCustomed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.com.
Quantity in Commerce78600
DistributionUS Distribution to Florida, New York and 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.
-
-