Medline Convenience Kits with Recalled Swan-Ganz Catheters
Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to defects in the proximal injectate lumen hub that may leak or break, risking infection, medication loss, and blood loss.
What this means for you
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 classified this as Class II. The source explicitly describes potential serious harms (infection, blood loss) but does not report any cases of illness or injury. This meets the rubric for High (score 3): a medical device recall with risk of harm where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits (model DYNJ8407, UDI-DI 10198459704543, Lot 26DBB599) containing Swan-Ganz catheters. Becton Dickinson (BD) recalled the catheters due to complaints of leaks and breakage involving failures of the blue proximal injectate lumen hub.
The defective hub has led to instances of leakage, lumen damage, and breakage. These failures may result in infection, medication loss, and blood loss.
The kits were distributed nationwide in Arizona, California, Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin. A total of 9,272 kits were affected by this recall.
If you have one of these kits, contact Medline Industries for instructions on how to return or replace the product.
The recalled product
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407
- Manufacturer
- Medline Industries, LP
- Hazard
- catheter-defect
- leak
- breakage
- infection-risk
- blood-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 10198459704543 Lot 26DBB599
Distribution
Distributed nationwide across the United States.
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