Z-0067-06

Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized

Name: Z-0067-06 Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized
Creator: Remington Medical Inc.
Published: 2005-06-06
License: https://open.fda.gov/license/

Remington Medical / initiated 2005-06-06 / Terminated

FDA source

Remington Medical Inc. began a recall of Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized on 2005-06-06. The reason FDA records is "The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0067-06
Status: Terminated
Initiated: 2005-06-06
Posted: 2005-10-21
Terminated: 2006-10-10
Recalling firm: Remington Medical
Product: Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized.
Product code: GWG Endoscope, Neurological
Reason for recall: The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
FDA root cause: Other
Action: A recall letter was sent to each consignee July 6th through July 11, 2005 requesting that they examine any product on hand. The letter also indicated that a representative would be contacting them in follow-up to the letter.
Quantity in commerce: 1500 units
Distribution: AL, AR, CA, CO, FL, GA, IN, IA, MD, MN, MO, NE, NV, NY, OH, OK, OR, PA, RI, TX, UT, VA, WA, WI
Product codes and lots: Lot No. 041603, 041731, 050201, 050274

Product code GWG

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)