Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability
Medline is recalling 16 non-sterile left heart kits sold to accounts without sterilization capabilities. The kits require sterilization 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 is classified as FDA Class II and involves a risk-of-harm product (non-sterile medical kits) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Medline Industries Inc is recalling 16 units of Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco. These are non-sterile kits intended to be sterilized prior to use. The recall is due to the kits being sold to accounts that do not have the capabilities to sterilize them.
The affected products are identified by Lot 5554476 with an expiration date of 11/30/2022. The kits were distributed nationwide in the United States, including in California, Colorado, Connecticut, Ohio, Texas, and New York. The kits are used in NAMIC Cath Lab and Interventional Radiology (IR) settings.
The FDA has classified this as a Class II recall. No specific illnesses or injuries have been reported in the source text. Users should stop using the affected kits and contact Medline Industries Inc for instructions on return or replacement.
The recalled product
- Product
- Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - 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 manu
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical 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 (2)
- Lot 5554476
- 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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