Kit Model #650304917, MTO Protection Station Plus with Drape - 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).
Reported: October 14, 2020 Initiated: September 14, 2020 #Z-0064-2021
Product Description
Kit Model #650304917, MTO Protection Station Plus with Drape - 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).
Reason for Recall
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Details
- Recalling Firm
- Medline Industries Inc
- Units Affected
- 80 kits
- Distribution
- US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Kit Model #650304917, MTO Protection Station Plus with Drape - 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).. Recalled by Medline Industries Inc. Units affected: 80 kits.
Why was this product recalled? ▼
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0064-2021.
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