Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability
Medline Industries is recalling 16 non-sterile cath lab 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 (medical device) where the hazard is the use of non-sterile items without sterilization, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 16 units of Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp. These are NAMIC Cath Lab and Interventional Radiology (IR) Kits, which consist of combinations of devices from the NAMIC Fluid Management product families and other devices designed by original equipment manufacturers.
The recall was initiated because these non-sterile kits, which are intended to be sterilized prior to use, were sold to accounts that do not have the capabilities to perform sterilization. This creates a risk that the devices may be used without proper sterilization.
The affected kits were distributed nationwide in the United States, including in California, Colorado, Connecticut, Ohio, Texas, and New York. The lot number is not recorded, and the expiration date is not identified. Users should stop using these kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - 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 — Cath Lab Kits
- Hazard
- Affected units
- 16
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 (1)
- Lot is not recorded and expiration date is not identified
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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