Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability
Medline Industries is recalling 60 non-sterile Left Heart Kits sold to accounts without sterilization capabilities. The kits were distributed nationwide.
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: The FDA classified this as a Class II recall. The hazard involves the use of non-sterile medical devices in a clinical setting without prior sterilization, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 60 units of Kit Model #65021652, MTO Left Heart Kit United Reg Health. These are non-sterile kits intended to be sterilized prior to use. The recall was initiated because the kits were sold to accounts that did not have the capabilities to sterilize them before use.
The affected products are identified by Lot 5574586 with an expiration date of 01/31/2023. The kits were distributed nationwide in the United States, including in the states of California, Colorado, Connecticut, Ohio, Texas, and New York. The products are used in Cath Lab and Interventional Radiology (IR) settings.
Healthcare facilities and accounts that purchased these kits should stop using them immediately and contact Medline Industries Inc for instructions on how to return or dispose of the products. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 5574586
- Exp 01/31/2023
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medline Industries Inc 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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