Medline Convenience Kits with Swan-Ganz Catheters Recalled
Medline Industries 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: This is an FDA Class II medical device recall involving a structural failure that may cause infection, medication loss, or blood loss. Although no reported illnesses or injuries are stated in the source text, the risk of serious harm—including infection and blood loss—from a device used in invasive cardiac procedures justifies a High severity rating.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits containing Swan-Ganz Catheters (model RIGHT HEART CATH PACK CTX, UDI-DI 10195327345044). The catheters were originally recalled by the manufacturer Becton Dickinson (BD) due to failures of the blue proximal injectate lumen hub.
BD has received complaints of leaks and breakage involving these hub failures. The defect has resulted in instances of leakage, lumen damage, and catheter breakage.
These problems may lead to infection, medication loss, and/or blood loss. The affected kits were distributed nationwide to AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, and WI.
Consumers who have received these kits should stop using them and contact Medline Industries for further instructions or a replacement product.
The recalled product
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
- 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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