Kit Model #65193091 recall: Sterility Concern
Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices…
Why was Kit Model #65193091 recalled?
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 5619215, Exp 06/30/2023
- Product
- Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices…
- Recalling firm
- Medline Industries Inc
- Quantity
- 16 kits
- Distribution
- US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
- Recall date
- October 14, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)