Medline Convenience Kits with Swan-Ganz Catheters Recalled for Defects
Medline is recalling convenience kits containing Swan-Ganz catheters due to failures of the proximal injectate lumen hub that can cause leaks, lumen damage, and breakage, potentially resulting in 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a critical cardiac catheter with potential for serious patient harm including infection, medication loss, and blood loss. Class II recalls paired with risk of hospitalization-level complications meet the Severe threshold.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits containing Swan-Ganz catheters manufactured by Becton Dickinson (BD). The catheters have experienced failures of the blue proximal injectate lumen hub, leading to leaks, lumen damage, and breakage.
These defects may result in infection, medication loss, and/or blood loss. A total of 9,272 kits have been distributed nationwide in Arizona, California, Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.
Healthcare facilities and individuals who have received these kits should immediately discontinue use and contact Medline for instructions on replacement or return. Affected lot numbers and UDI codes are available from the FDA and Medline.
The recalled product
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
- 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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