FDA-Device2026-07-08Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

Medline Convenience kits contain Swan-Ganz catheters with a defective connector (blue hub) that can leak, break, or damage the internal lumen. This defect may lead to medication loss, blood loss, or infection during medical use.

  • Check if you have one of the affected Medline Convenience kits (CARDIAC MAJOR, HEART A, OPEN HEART, SILVER CROSS OPEN HEART, or VPH OPEN HEART).
  • Do not use the Swan-Ganz catheter from the kit if the lot number matches those listed in the recall notice.
  • Contact Medline customer service or your healthcare facility for instructions on replacement or proper disposal.
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 CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2607-2026

More Medline recalls

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