openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 8
Kit Model #65021652, MTO Left Heart Kit United Reg Health - 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).
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code information
Lot 5574586, Exp 01/31/2023
Distribution pattern
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
device · product 2 of 8
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - 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).
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code information
Lot 5554524, Exp 12/31/2022; second lot with no lot recorded and no exp identified
Distribution pattern
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
device · product 3 of 8
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - 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).
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code information
Lot 5551869, Exp 01/31/2022
Distribution pattern
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
device · product 4 of 8
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).
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code information
Lot 5550988. Exp not identified but manufactured 11/22/2019; Second included lot with unidentified lot number and no identified exp
Distribution pattern
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
device · product 5 of 8
Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - 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).
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code information
Lot is not recorded and expiration date is not identified
Distribution pattern
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
device · product 6 of 8
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - 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).
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code information
Lot 5551428, Exp 11/30/2022
Distribution pattern
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
device · product 7 of 8
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).
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code information
Lot 5554476, Exp 11/30/2022
Distribution pattern
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
device · product 8 of 8
Kit Model #65193091, MTO Left Heart Kit - 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).
