Medline Convenience Kits Containing Recalled Swan-Ganz Catheters
Medline is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or 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 classified this as Class II, and the hazard involves risk of serious harm (infection, blood loss) from a defective medical device where failures have already been reported. Although no specific illnesses are documented in this notice, the medical device defect with reported complaints meets the High severity threshold.
Plain-English summary
Medline Industries, LP is recalling convenience kits that contain Swan-Ganz catheters originally recalled by Becton Dickinson (BD). The catheters have a defect in the blue proximal injectate lumen hub that can leak or break.
Complaints received by BD describe leaks, lumen damage, and breakage of the hub. These failures may result in infection, loss of medication, or blood loss.
The affected kits (model numbers KIT GERMANTOWN CABG, KIT UNIVERSITY CABG PACK, and OH MED RN CDS) were distributed nationwide to healthcare facilities in Arizona, California, Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin. Approximately 9,272 kits are affected.
Facilities that have received these kits should stop using them immediately and consult their local medical device coordinator or contact Medline for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
- 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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