• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medline

  • 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 Medlinesee related information
Date Initiated by FirmMarch 22, 2024
Date PostedAugust 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2697-2024
Recall Event ID 94356
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
Code Information UDI/DI 40888277422279 (package), 0888277DC265NSKX (unit), Lot Numbers: 670220512, 670220609, 670220621, 670220629, 670220712, 670220803, 670220815, 670220914, 670221009
Recalling Firm/
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer Reason
for Recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
FDA Determined
Cause 2
Under Investigation by firm
ActionMedline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.
Quantity in Commerce88703 units
DistributionWorldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-