FDA Medical Device Recalls (openFDA)
Remington Medical Inc.: Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.
- Recall number
- Z-0065-06
- Recalling firm
- Remington Medical Inc.
- Product
- Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.
- Status
- Terminated
- Initiated
- 2005-06-06
- Posted
- 2005-10-21
- Terminated
- 2006-10-10
- Reason
- 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.
- 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
- 3180 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
- Lot, serial or model codes
- Lot No. 040508, 041111, 042116, 042367, 043146, 050077, 041464
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GWG
- Firm FEI
- 1000132370
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28