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 dynarex Specimen Containers

  • 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 dynarex Specimen Containerssee related information
Date Initiated by FirmMarch 03, 2016
Create DateJune 28, 2016
Recall Status1 Terminated 3 on June 06, 2018
Recall NumberZ-2057-2016
Recall Event ID 73584
Product Classification Container, specimen, non-sterile - Product Code NNI
Productdynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
Code Information Lot Numbers: 31899, 32014, 32015, 32410 & 32411
FEI Number 2431014
Recalling Firm/
Manufacturer		 Dynarex Corporation
10 Glenshaw St
Orangeburg NY 10962-1207
For Additional Information ContactCustomer Service Dept.
845-365-8200
Manufacturer Reason
for Recall		Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
FDA Determined
Cause 2		Labeling False and Misleading
ActionOn March 2, 2016, dynarex Corporate Headquarters distributed Voluntary Device Recall notices and Recall Verification Forms to their customers via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to examine their stock immediately to determine if they have any of the lots listed on hand. If so, discontinue distributing and quarantine the product immediately. Promptly contact the Dynarex Credit & Return representative Avi Celnick (845-365-8200 Ext 6644) to arrange for product return. Customers account will be credited for all returned products. All customers are advised to complete the Voluntary Recall Verification Form and returm immediately via fax or e-mail to Vijay Sachdev (Fax 845-365-8238; v.sachdev@dynarex.com).
Quantity in Commerce399 cases/25 sleeves/20 cups & lids per sleeve
DistributionUS Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
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.
-
-