Medline Convenience kits recalled for defective Swan-Ganz catheters with leak risk
What this means
Medline Convenience kits contain Swan-Ganz catheters manufactured by Becton Dickinson (BD) that may leak or break due to a defect in the blue proximal injectate lumen hub. The defect can cause leakage, lumen damage, breakage, and potential infection, medication loss, or blood loss during use.
- Check if your facility received one of the affected kits (see lot numbers in FDA notice).
- Stop using affected kits immediately and segregate them.
- Contact Medline or your distributor for instructions on replacement or return.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2609-2026More Medline recalls
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