FDA-Device2026-07-08Class IIPROCESSING DEFECT

Medline Convenience kits with recalled Swan-Ganz catheters due to hub failure risk

OTHERNationwide distributionMedical devices

What this means

Medline Convenience kits contain Swan-Ganz catheters with a defective blue hub on the proximal injectate lumen that can leak, break, or damage the lumen. This defect can lead to leakage during use, loss of medication, blood loss, or infection.

  • Check if you have one of the affected lots: 21KBN891, 21KBO410, 22ABA676, 22ABY937, 22BBN909, 22BBT447, or 23ABO303.
  • Stop using the kit and contact Medline or your healthcare facility for guidance.
  • Report any injuries or problems with the catheter 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 DYNJ68530A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2612-2026

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