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U.S. Department of Health and Human Services

Class 2 Device Recall Medline convenience kits

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 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-0416-2027
Recall Event ID 100112
Product Classification Plastic surgery and accessories kit - Product Code FTN
ProductMedline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes LTP CDS-LF CDS980375M
Code Information UDI-DI 10198459447327 Lots 26CBO429 26DBD094
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.
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