MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power
FDA device recall Z-1868-2012 · posted 2012-06-26 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
- Action taken
- MedComp sent a "PRODUCT ALERT" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm requested the return of all affected product. Contact the firm at 215-256-4201 ext. 2225 for questions regarding this notice.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 30
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
- Date initiated
- 2012-04-02
- Date posted
- 2012-06-26
- Date terminated
- 2013-05-20
- 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 |