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 have a defect in the blue proximal injectate lumen hub. The hub can leak, break, or fail, potentially causing medication loss, blood loss, or infection during use.

  • Check if you have affected Medline Convenience CV Anesthesia Room Set Up kits (model numbers DYNJ905503D, DYNJ905503F, or DYNJ905503G).
  • Do not use affected kits. Contact Medline or your distributor for instructions on return or replacement.
  • Review lot numbers provided in the recall notice to confirm if your kits are affected.
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 CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2610-2026

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