FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Kit Model #650304917, MTO Protection Station Plus with Drape - 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 number
- Z-0064-2021
- Recalling firm
- Medline Industries Inc
- Product
- Kit Model #650304917, MTO Protection Station Plus with Drape - 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).
- Status
- Terminated
- Initiated
- 2020-09-14
- Posted
- not on file
- Terminated
- 2021-04-09
- Reason
- Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
- 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
- 80 kits
- Distribution
- US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
- Lot, serial or model codes
- Lot 5550988. Exp not identified but manufactured 11/22/2019; Second included lot with unidentified lot number and no identified exp
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEQ
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28