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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmMay 28, 2026
Date PostedJune 26, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2612-2026
Recall Event ID 99209
Product Classification Cardiac catheterization kit - Product Code OES
ProductMedline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
Code Information UDI-DI 10195327033620 Lots 21KBN891 21KBO410 22ABA676 22ABY937 22BBN909 22BBT447 23ABO303
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer Reason
for Recall		Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
FDA Determined
Cause 2		Process change control
ActionOn May 28, 2026, the firm notified customers via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce9,272 kits
DistributionUS Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, 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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