Kit Model #650600111 recall: Sterility Concern
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any…
Why was Kit Model #650600111 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 5551428, Exp 11/30/2022
- Product
- Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any…
- Recalling firm
- Medline Industries Inc
- Quantity
- 32 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)