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 Medline Iris Scissors, SingleUse, Curved, Standard 4.5

  • 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 Medline Iris Scissors, SingleUse, Curved, Standard 4.5see related information
Date Initiated by FirmApril 30, 2024
Date PostedJune 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2024-2024
Recall Event ID 94435
Product Classification Scissors, medical, disposable - Product Code JOK
ProductMEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
Code Information UDI/DI 10080196847273, Lot Numbers: 23GBV681, 23HBD138, 23IBF254, 23LBJ787
FEI Number 1417592
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		There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline Industries, LP issued a recall notice to its consignees on 04/30/2024 via email and USPS First Class Mail. The notice explained the issued, potential risk, and requested the product be destroyed. Those who further distributed the affected product were directed to notify those to whom the affected product was distributed.
Quantity in Commerce67811 units
DistributionWorldwide distribution - US Nationwide and the countries of Singapore, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-