Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline,
FDA device recall Z-0642-2007 · posted 2007-03-21 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- Reason for recall
- Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.
- Action taken
- An Urgent Medical Device Recall letter, dated December 12, 2006 was sent to affected hospitals Risk Manager beginning 12/12/2006. The letter describes the issue and product affected, requests that further distribution or use of any remaining product cease immediately, and provides information for returning product to Boston Scientific Replacement product will be issued for all recalled product returned from affected facilities. A Reply Verification Tracking Form is requested to be completed and returned to Boston Scientific by Wednesday, December 27, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 10 units
- Distribution
- US only to: FL, GA, IN, NY.
- Date initiated
- 2006-12-12
- Date posted
- 2007-03-21
- Date terminated
- 2007-07-20
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KATZEN THROMBOLYSIS GUIDEWIRE (K883880) | Medi-Tech, Inc. | 1989-04-06 |