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).
- Company
- Medline Industries Inc
- Recall Initiated
- September 14, 2020
- Terminated
- April 9, 2021
- Recall Number
- Z-0063-2021
- Quantity
- 20 kits
- Firm Location
- Northfield, IL
Reason for Recall
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Distribution
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Lot / Code Info
Lot 5551869, Exp 01/31/2022
Root Cause
Process design
Action Taken
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.