Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability
Medline Industries is recalling 32 non-sterile cath lab kits because they were sold to accounts without the capability to sterilize them prior to use.
What this means for you
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 medical device where the intended sterilization process could not be performed by the recipient, creating a risk of harm from non-sterile use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 32 units of Kit Model #650600111, MTO Left Heart St Francis Hosp - PG. These products 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. The affected products are identified by Lot 5551428 with an expiration date of 11/30/2022.
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 these kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - 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 manufac
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Cath Lab Kits
- Hazard
- Affected units
- 32
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 5551428
- Exp 11/30/2022
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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