9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection por
FDA device recall Z-1527-2015 · posted 2015-04-27 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- The dual port with catheters was not covered under FDA clearance.
- Action taken
- Sales reps were notified by email on/about January 28, 2015, and instructed to notify their medical facilities and provide the recall letter. This will be accomplished by either email, telephone, or visit. Every consignee will be requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received.
- Root cause
- PMA
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 325
- Distribution
- Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
- Date initiated
- 2015-01-28
- Date posted
- 2015-04-27
- Date terminated
- 2017-01-06
- 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 |
|---|---|---|
| JET PORT PLUS CATHETER SYSTEM (K000125) | Clinical Plastic Products SA | 2000-04-12 |