COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic
FDA device recall Z-0637-2007 · posted 2007-03-16 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- These catheters do not include the proximal sidehole as required by the specification.
- Action taken
- Consignees were notified by phone on 1/2/07 and instructed to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 100
- Distribution
- Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina.
- Date initiated
- 2007-01-02
- Date posted
- 2007-03-16
- Date terminated
- 2007-12-05
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABRM CATHETER (K950118) | Cook, Inc. | 1996-02-08 |