8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. C
FDA device recall Z-1626-2012 · posted 2012-05-18 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- 50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
- Action taken
- On April 12, 2012, MedComp sales representatives and the foreign distributor were notified via e-mail with a "Product Alert" notification. The issue was described and requested actions were provided to recipients.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 50 trays
- Distribution
- Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain.
- Date initiated
- 2012-04-12
- Date posted
- 2012-05-18
- Date terminated
- 2013-07-18
- Location
- Harleysville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) (K070003) | Medcomp | 2007-05-15 |