Medline Recalls Non-Sterile Radiology Kits Sold Without Sterilization Capability
Medline Industries is recalling 20 non-sterile radiology kits that were sold to accounts without the ability to sterilize them prior to use.
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 recall involves a risk-of-harm product (non-sterile medical devices used in invasive procedures) where the hazard is the potential for infection due to lack of sterilization, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 20 units of Kit Model #650301023, MTO Radiology Kit Cleveland Clinic. These kits are intended for use in Cath Lab and Interventional Radiology (IR) settings and consist of devices from the NAMIC Fluid Management product families.
The recall was initiated because the non-sterile kits were sold to accounts that do not have the capabilities to sterilize the devices prior to use. The affected products are identified by Lot 5551869 with an expiration date of 01/31/2022.
The products were distributed nationwide in the United States, including in the states of California, Colorado, Connecticut, Ohio, Texas, and New York. Users should stop using the affected kits and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - 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 — Radiology Kits
- Affected units
- 20
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 5551869
- Exp 01/31/2022
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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