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 SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports

  • 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 SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports see related information
Date Initiated by Firm September 13, 2017
Date Posted September 29, 2017
Recall Status1 Terminated 3 on May 25, 2018
Recall Number Z-3240-2017
Recall Event ID 78117
510(K)Number K843523  
Product Classification Container, i.V. - Product Code KPE
Product SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Code Information UDI: 50812496011850, Lot Numbers: 28990, 29093, 29135, 29244.
Recalling Firm/
Manufacturer		 The Metrix Company
4400 Chavenelle Rd
Dubuque IA 52002-2655
For Additional Information Contact Michael Regan
563-556-8800
Manufacturer Reason
for Recall		 The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.
FDA Determined
Cause 2		 Error in labeling
Action Recall letters will be sent to each consignee (distributors) via FedEx. The letter requested the following: "The Metrix Company is asking all customers to follow the steps below: 1. Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Destroy all affected products and dispose/recycle in a manner consistent with your local waste disposal authority. 4. Complete the Response form and return it to The Metrix Company according to the instructions on the form." Distributors were instructed to contact their customers about the recall. The product is to be destroyed in the field.
Quantity in Commerce 50 cases of 200 units
Distribution AZ, MA, IL, FL
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 = KPE and Original Applicant = POLYMER TECHNOLOGY CORP.
-
-