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).
Recall
- Recall Number
- Z-0065-2021
- Event Number
- 86503
- Firm
- Medline Industries Inc
- FEI Number
- 1417592
- Product Code
- OEQ
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- September 14, 2020
- Terminated
- April 9, 2021
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
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.
Medline Industries, Inc. had provided each consignee with a response form to return via email. Each Response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to our recall notification in the allotted time. Medline has provided each consignee with a response form to return or email. Each Response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to the field action notification in the allotted time.
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
16 kits