ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number:
FDA device recall Z-1098-05 · posted 2005-08-06 · Terminated
Recall details
- Recalling firm
- United States Surgical Corporation
- Reason for recall
- The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- Action taken
- United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 633 units
- Distribution
- Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
- Date initiated
- 2005-06-30
- Date posted
- 2005-08-06
- Date terminated
- 2010-09-14
- 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 |