Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120039
FDA device recall Z-1150-06 · posted 2006-06-17 · Terminated
Recall details
- Recalling firm
- United States Surgical
- Reason for recall
- The 9F device may contain a 10 F sheath instead of the 9F
- Action taken
- United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 720 units
- Distribution
- Nationwide and International Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec
- Date initiated
- 2006-05-22
- Date posted
- 2006-06-17
- Date terminated
- 2007-12-12
- Location
- North Haven, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERCUTANEOUS INTRODUCER KIT (K902135) | Device Labs, Inc. | 1990-08-01 |