# Biotronix 2000 Inc. (Lg Technologies) · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Biotronix 2000 Inc. (Lg Technologies) · 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 Needlesafe; all models; including NX3000; NX2000; NX1000; NX5000 SDS | Sharpes Container sold with Model NX5000 SDS and alone; product code is 80 K - - ZH Introducer, Syringe Needle | 80 M - - MK Container, Sharps; date published is 01/23/2019; address is 2185 Rue Michelin , Laval, QC CANADA, verified against its source on 2026-09-16.

- **Firm:** Biotronix 2000 Inc. (Lg Technologies) _(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:** 2185 Rue Michelin , Laval, QC CANADA _(verified: appears in the quote below)_
- **Date published:** 01/23/2019 _(verified: appears in the quote below)_
- **Product code:** 80 K - - ZH Introducer, Syringe Needle | 80 M - - MK Container, Sharps _(verified: each item appears in the quote below)_
- **Product:** Needlesafe; all models; including NX3000; NX2000; NX1000; NX5000 SDS | Sharpes Container sold with Model NX5000 SDS and alone _(verified: each item appears in the quote below)_
- **FDA notes:** 8/19/1998 | 8/19/1998 _(verified: each item appears in the quote below)_

## What the source says

> Biotronix 2000 Inc. (Lg Technologies) Date Published : 01/23/2019 2185 Rue Michelin , Laval, QC CANADA 80 K - - ZH Introducer, Syringe Needle Date Published: 01/23/2019 Desc: Needlesafe; all models; including NX3000; NX2000; NX1000; NX5000 SDS Notes: 8/19/1998 80 M - - MK Container, Sharps Date Published: 01/23/2019 Desc: Sharpes Container sold with Model NX5000 SDS and alone Notes: 8/19/1998

## 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/).