Z-0065-2021Class II

Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp -

Name: Z-0065-2021 Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp -
Creator: Medline Industries Inc
Published: 2020-09-14
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-09-14 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of 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... on 2020-09-14. FDA classified it as Class II and gives the reason as "Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0065-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-14
Posted: 2020-10-07
Terminated: 2021-04-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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 manufactured by original equipment manufacturers (OEM).
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 16 kits
Distribution: US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Product codes and lots: Lot is not recorded and expiration date is not identified

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0065-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0061-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-07
Z-0062-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-07
Z-0063-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-07
Z-0064-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-07
Z-0065-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-07
Z-0066-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-07
Z-0067-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-07
Z-0068-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-07

Product code OEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)