medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1
FDA device recall Z-2235-2010 · posted 2010-08-17 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.
- Action taken
- Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 47 units
- Distribution
- Worldwide Distribution -- USA, including states of NC and TX and country of Israel.
- Date initiated
- 2010-07-02
- Date posted
- 2010-08-17
- Date terminated
- 2010-10-13
- 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 |