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 CARDINAL HEALTH brand

  • 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 CARDINAL HEALTH brand see related information
Date Initiated by Firm July 18, 2019
Create Date November 01, 2019
Recall Status1 Terminated 3 on May 18, 2020
Recall Number Z-0272-2020
Recall Event ID 83762
Product Classification Container, specimen, sterile - Product Code FMH
Product Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case
Catalog number: CHB13904
Code Information Lot # 1236428, 1237502, 1237804, 1238412,1238880, 1239711, 1241129, 1242233, 1243303,1243863, 1246080,1246545,1247463,1248348, 1248489, 1249612, 1250496,1250723, 1251447,1251519, 1251993, 1253294
Recalling Firm/
Manufacturer		 Thermo Fisher Scientific (Monterrey)
Blvd Apodaca 500
Apodaca Technology Park
Apodaca Nuevo Leon 66600 Mexico
Manufacturer Reason
for Recall		 Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
FDA Determined
Cause 2		 Equipment maintenance
Action 1. Please notify to any organizations that have received affected product. 2. If you have any affected product please contact Technical Support Team regarding free-of-charge product replacement. Technical Support: Phone - +1-800-625-4327 Email - technicalsupport@thermofisher.com
Quantity in Commerce 2,979,600 each
Distribution OH
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.
-
-