REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion
FDA device recall Z-0898-2013 · posted 2013-02-28 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
- Action taken
- Medcomp sent a notification letter dated December 13, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns call 215-256-4201
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 785
- Distribution
- USA Nationwide Distribution including the state of PA.
- Date initiated
- 2012-12-13
- Date posted
- 2013-02-28
- Date terminated
- 2013-07-31
- 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 |
|---|---|---|
| PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) (K081904) | Medcomp | 2008-09-23 |