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 convenience kits

  • 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 convenience kitssee related information
Date Initiated by FirmSeptember 24, 2026
Date PostedNovember 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0414-2027
Recall Event ID 100112
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductMedline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes ADULT HEART CIRCULATOR KIT DYKS1120G AHT CVOR CABG CDS983346K CARDIOPULMONARY MPH DYNJT5258A CV HEART GOWN & DRAPE PACK A DYNJ912460 FEM POP CDS982028W OPEN HEART PROCEDURE CDS980895X VASCULAR DYNJ911429 ENDOSCOPIC SKULL BASE DYNJ908362F
Code Information DYKS1120G UDI-DI 10198459335808 Kit lots 26DMI051 26EMJ713 CDS983346K UDI-DI 10198459701993 Kit lot 26DBH084 DYNJT5258A UDI-DI 10198459661495 Kit lot 26DBB503 DYNJ912460 UDI-DI 10198459726880 Kit lot 26DLA824 CDS982028W UDI-DI 10198459385605 Kit lot 25LMH727 CDS980895X UDI-DI 10198459662904 Kit lot 26EMA865 DYNJ911429 UDI-DI 10198459341014 Kit lots 26AMJ586 26CMF189 26FME829 26FMG294 DYNJ908362F UDI-DI 10198459308581 Kit lot 25LLA930
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
800-633-5463
Manufacturer Reason
for Recall		Convenience kits contain additional product codes and lots of recalled CliniClean Pericare Wipes identified by manufacturer. Wipes may be contaminated with a lubricant used in the manufacturing process. Use of affected wipes may cause localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare may increase the risk of localized infection or catheter-associated urinary tract infection.
FDA Determined
Cause 2		Process change control
ActionThis is an update to a previously issued letter due to the manufacturer/supplier identifying additional lots of affected product. On September 24, 2026, customers were notified of the additional products and lots affected. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a sticker indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
Quantity in Commerce7,043 kits
DistributionUS Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IN, LA, MA, MN, MO, MS, MT, NC, NE, NV, NY, OH, OK, RI, SC, TN, TX, WI.
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.
-
-