Myelotec Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0, LB0020-1, LB0020-2, LB0020-3, and L
FDA device recall Z-0587-2008 · posted 2008-04-10 · Terminated
Recall details
- Recalling firm
- Myelotec, Inc.
- Reason for recall
- Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.
- Action taken
- Consignees were first notified by phone on 12/19/2007. A follow up Urgent Label Insert Recall Notification letter was sent via certified mail on/about 12/28/2007. Consignees were instructed to remove the subject label inserts from the affected product in inventory, replace with the enclosed revised label inserts and to complete the attached Recall and Accountability Form. The incorrect label inserts were to be returned, via package provided to Myelotec.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 1,252 shipping containers
- Distribution
- Worldwide Distribution --- USA including states of AL, CA, CT, FL, GA, ID, IN, ME, MN, NH, NJ, NY, OH, and OR, and countries of Aurba, Korea, Japan, Switzerland, South Africa, UK.
- Date initiated
- 2007-12-19
- Date posted
- 2008-04-10
- Date terminated
- 2008-12-03
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MYELOTEC VIDEO GUIDED CATHETER (K980734) | Myelotec, Inc. | 1998-08-11 |