Medline Industries, Lp: General Surgery Tray
Recall Summary Medline Convenience kits containing Swan-Ganz catheters (used in open heart surgery) are being recalled because the catheters have a defective blue hub that can leak, break, or damage the lumen. These defects may result in infection, medication loss, or blood loss. The affected kits were distributed nationwide, primarily across Arizona, California, Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-28
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/db13ead8-ee43-4eae-94ba-bd0e9b9cf84a