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Terminated

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

FDA Recall Z-0067-06 · Posted 2005-10-21

Recalling FirmRemington Medical Inc.
Recall StatusTerminated
Product CodeGWG
Date Initiated2005-06-06
Date Terminated2006-10-10
Product Quantity1500 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

AL, AR, CA, CO, FL, GA, IN, IA, MD, MN, MO, NE, NV, NY, OH, OK, OR, PA, RI, TX, UT, VA, WA, WI

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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