Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized.
FDA device recall Z-0067-06 · posted 2005-10-21 · Terminated
Recall details
- Recalling firm
- Remington Medical Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWG
- Quantity affected
- 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
- Date initiated
- 2005-06-06
- Date posted
- 2005-10-21
- Date terminated
- 2006-10-10
- Location
- Alpharetta, GA
Monitor recalls programmatically
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