FDA-Device2026-07-08Class IIPROCESSING DEFECT

Medline Convenience kits recalled for defective Swan-Ganz catheters with leak risk

OTHERNationwide distributionMedical devices

What this means

Medline Convenience kits contain Swan-Ganz catheters manufactured by Becton Dickinson (BD) that may leak or break due to a defect in the blue proximal injectate lumen hub. The defect can cause leakage, lumen damage, breakage, and potential infection, medication loss, or blood loss during use.

  • Check if your facility received one of the affected kits (see lot numbers in FDA notice).
  • Stop using affected kits immediately and segregate them.
  • Contact Medline or your distributor for instructions on replacement or return.
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 KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2609-2026

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