# Ark Bio Medical Canada Corp · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Ark Bio Medical Canada Corp · 89-08 · CANADA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CANADA; product is Ark Bio Microwave Plasma Defroster; product code is 81 K - - ZL Device, Warming, Blood and Plasma; date published is 10/07/2016; address is 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA, verified against its source on 2026-09-16.

- **Firm:** Ark Bio Medical Canada Corp _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CANADA _(verified: appears in the quote below)_
- **Address:** 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA _(verified: appears in the quote below)_
- **Date published:** 10/07/2016 _(verified: appears in the quote below)_
- **Product code:** 81 K - - ZL Device, Warming, Blood and Plasma _(verified: appears in the quote below)_
- **Product:** Ark Bio Microwave Plasma Defroster _(verified: appears in the quote below)_

## What the source says

> Ark Bio Medical Canada Corp Date Published : 10/07/2016 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA 81 K - - ZL Device, Warming, Blood and Plasma Date Published: 10/07/2016 Desc: Ark Bio Microwave Plasma Defroster

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).