CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco recalled
Medline Industries is recalling Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco, distributed nationwide in the US. The recall was initiated on 14 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0067-2021
- FDA event ID
- 86503
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2020
- FDA classified
- 7 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 14 Sep 2020 | Recall initiated by company | |
| 7 Oct 2020 | Classified by FDA | +23 days |
| 14 Oct 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 manufactured by original equipment manufacturers (OEM).
Where it was distributed
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Questions about this recall
Is Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco recalled?
Yes. Medline Industries recalled Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco on 14 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0067-2021.
Why was it recalled?
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Which lots are affected?
Lot 5554476, Exp 11/30/2022
Where was it sold?
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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