Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets, Size 8 French, Sterile: Single Use/Disposable Radiopague Contents Ethylene Oxide Sterilized
This recall has been terminated (originally issued October 21, 2005).
- Company
- Remington Medical Inc.
- Recall Initiated
- June 6, 2005
- Posted
- October 21, 2005
- Terminated
- October 10, 2006
- Recall Number
- Z-0066-06
- Quantity
- 1500 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
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.
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 / Code Info
Lot No. 043003, 042674, 042313
Root Cause
Other
Action Taken
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.
More recalls by Remington Medical Inc.
Remington MEDICAL Drainage Bag, REF 600-D;
Dec 5, 2023
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
Electrical extension cable...
Apr 9, 2014