FDA-Device2026-07-08Class IIPROCESSING DEFECT

Medline Convenience kits with recalled Swan-Ganz catheters for proximal hub leakage risk

OTHERNationwide distributionMedical devices

What this means

Medline's Convenience kits contain Swan-Ganz catheters that were recalled by manufacturer Becton Dickinson due to failures in the blue proximal injectate lumen hub. These failures can cause leaks, lumen damage, and breakage, which may result in infection, medication loss, or blood loss.

  • If your facility received affected kits (lots 24EBL051, 24GBG271, 24ALA227, 24BLA369, 24CLA108, 24CLA518, 24DLA082, 24ELB053, or 24ILA112), stop using them immediately.
  • Contact Medline or Becton Dickinson for instructions on returning or disposing of the affected catheters.
  • Review patient records to identify any patients who may have received these catheters and assess for potential complications.
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 OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2611-2026

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