Medline Convenience kits recalled for defective Swan-Ganz catheters with leak and breakage risk
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
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-2607-2026More Medline recalls
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