Recalls / —
—#183840
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 manufactured by original equipment manufacturers (OEM).
- FDA product code
- OEQ — Angiography/Angioplasty Kit
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Lot 5574586, Exp 01/31/2023
Why it was recalled
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Root cause (FDA determination)
Process design
Action the firm took
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.
Recalling firm
- Firm
- Medline Industries Inc
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Timeline
- Recall initiated
- 2020-09-14
- Terminated
- 2021-04-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #183840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.