# MAQILADORA TAMAULIPAS S.A. de C.V. · 89-08 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For MAQILADORA TAMAULIPAS S.A. de C.V. · 89-08 · MEXICO, 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 MEXICO; product is Thermofleet Blanket | Thermofleet Blanket; product code is 79 E - - RY Drape, Surgical, Ent | 80 K - - ME Bedding, Disposable, Medical; date published is 01/22/2010; address is 2 CENTARIO ESQ. Y GUERRERO , Allende 512 , SAN FERNANDO, TAMAULIPAS MEXICO, verified against its source on 2026-09-16.

- **Firm:** MAQILADORA TAMAULIPAS S.A. de C.V. _(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:** MEXICO _(verified: appears in the quote below)_
- **Address:** 2 CENTARIO ESQ. Y GUERRERO , Allende 512 , SAN FERNANDO, TAMAULIPAS MEXICO _(verified: appears in the quote below)_
- **Date published:** 01/22/2010 _(verified: appears in the quote below)_
- **Product code:** 79 E - - RY Drape, Surgical, Ent | 80 K - - ME Bedding, Disposable, Medical _(verified: each item appears in the quote below)_
- **Product:** Thermofleet Blanket | Thermofleet Blanket _(verified: each item appears in the quote below)_
- **FDA notes:** Class II Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH. | Class I Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH. _(verified: each item appears in the quote below)_

## What the source says

> MAQILADORA TAMAULIPAS S.A. de C.V. Date Published : 01/22/2010 2 CENTARIO ESQ. Y GUERRERO , Allende 512 , SAN FERNANDO, TAMAULIPAS MEXICO 79 E - - RY Drape, Surgical, Ent Date Published: 01/22/2010 Desc: Thermofleet Blanket Notes: Class II Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH. 80 K - - ME Bedding, Disposable, Medical Date Published: 01/22/2010 Desc: Thermofleet Blanket Notes: Class I Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH.

## 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/).