FDA (Devices) recall action 86503

Medline Industries Inc recalled 8 products on 2020-10-14

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2020-10-14
Critical: 0
Units: 320

Why these products were recalled

Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2020-10-14
Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability
Medline Industries is recalling 16 non-sterile Left Heart Kits sold to facilities without sterilization capabilities. The kits were intended to be sterilized prior to use.
Product
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…
Category
Distribution
7 states
HighFDA (Devices)··2020-10-14
Medline Recalls Non-Sterile Vascular Surgery Kits Sold Without Sterilization Capability
Medline Industries is recalling 80 non-sterile vascular surgery kits sold to accounts without sterilization capabilities. The kits were distributed nationwide, including in CA, CO, CT, OH, TX, and NY.
Product
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…
Category
Distribution
7 states
HighFDA (Devices)··2020-10-14
Medline Recalls Non-Sterile MTO Protection Station Plus Kits
Medline is recalling 80 non-sterile MTO Protection Station Plus kits because they were sold to facilities without sterilization capabilities.
Product
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…
Category
Distribution
7 states
HighFDA (Devices)··2020-10-14
Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability
Medline is recalling 16 non-sterile left heart kits sold to accounts without sterilization capabilities. The kits require sterilization prior to use.
Product
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…
Category
Distribution
7 states
HighFDA (Devices)··2020-10-14
Medline Recalls Non-Sterile Radiology Kits Sold Without Sterilization Capability
Medline Industries is recalling 20 non-sterile radiology kits that were sold to accounts without the ability to sterilize them prior to use.
Product
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…
Category
Distribution
7 states
HighFDA (Devices)··2020-10-14
Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability
Medline Industries is recalling 60 non-sterile Left Heart Kits sold to accounts without sterilization capabilities. The kits were distributed nationwide.
Product
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…
Category
Distribution
7 states
HighFDA (Devices)··2020-10-14
Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability
Medline Industries is recalling 32 non-sterile cath lab kits because they were sold to accounts without the capability to sterilize them prior to use.
Product
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…
Category
Distribution
7 states
HighFDA (Devices)··2020-10-14
Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability
Medline Industries is recalling 16 non-sterile cath lab kits that were sold to accounts without the ability to sterilize them prior to use.
Product
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…
Category
Distribution
7 states