Medline Convenience Kits with Recalled Swan-Ganz Catheters
Medline Convenience kits containing Swan-Ganz catheters are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may lead to infection, medication loss, and 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 medical device recall involving a structural defect (lumen hub failure) in critical cardiovascular catheters that may result in serious harm including infection, medication loss, and blood loss. Although no reported illnesses or injuries are stated in the source, the risk-of-harm nature of the defect and the Class II classification warrant a Severe rating.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits containing Swan-Ganz catheters that were manufactured by Becton Dickinson (BD). The catheters have a defect in the blue proximal injectate lumen hub that can leak or break.
The defect may result in lumen damage, breakage, leakage, and potentially infection, medication loss, and blood loss. Approximately 9,272 kits have been distributed nationwide to facilities in Arizona, California, Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.
Affected kits are identified by UDI-DI numbers 10193489430295, 10193489967272, and 10198459200397, with multiple lot numbers listed by the FDA. Healthcare facilities that have received these kits should stop using them and contact Medline Industries for instructions on how to return or dispose of the product.
The recalled product
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
- 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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