FDA-Device2026-07-08Class IIPROCESSING DEFECT
Medline Convenience kits recalled for Swan-Ganz catheters with hub failure risk
Nationwide distributionMedical devices
What this means
Medline Convenience kits contain Swan-Ganz catheters with a defective blue hub that can leak, break, or damage the lumen. This defect may cause medication loss, blood loss, or infection during use.
- Check if you have an affected kit (model RIGHT HEART CATH PACK CTX, UDI-DI 10195327345044, lot numbers 23DBI807 through 26DBE720).
- Do not use the kit if you have one of the affected lots.
- Contact Medline or your healthcare facility for guidance on replacement or safe disposal.
- Report any injuries or complications to the FDA MedWatch program.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Affected count
9,272 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2606-2026More Medline recalls
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