—#183841

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 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 5554524, Exp 12/31/2022; second lot with no lot recorded and no exp identified

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 #183841. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.