Medline Convenience Kits with Recalled Swan-Ganz Catheters
Medline Convenience kits containing recalled Swan-Ganz catheters may leak or break at the proximal injectate lumen hub, risking infection, medication loss, and blood loss.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with a structural defect (lumen hub failure) that presents a risk of harm including infection, medication loss, and blood loss. The source does not report any illnesses or injuries yet, which limits the score to 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits (model RIGHT HEART CATH PACK CTX, UDI-DI 10195327033620) containing Swan-Ganz catheters manufactured by Becton Dickinson (BD). These kits have been distributed nationwide in Arizona, California, Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin. A total of 9,272 kits are affected.
The recalled catheters have a defect in the blue proximal injectate lumen hub that can cause leaks, lumen damage, or breakage. Becton Dickinson has received complaints of these failures.
If the hub fails, it may lead to leakage of medication, loss of blood, or infection. Healthcare facilities and clinicians who have received these kits should stop using them and contact Medline Industries or Becton Dickinson for replacement or further instructions. Affected lot numbers are 21KBN891, 21KBO410, 22ABA676, 22ABY937, 22BBN909, 22BBT447, and 23ABO303.
The recalled product
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
- Manufacturer
- Medline Industries, LP
- Affected units
- 9,272
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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