Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Component
FDA device recall Z-0937-2013 · posted 2013-03-11 · Terminated
Recall details
- Recalling firm
- Vygon Corporation
- Reason for recall
- 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
- Churchill Medical Systems sent a letter to their consignees on December 19, 2012.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 210
- Distribution
- Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
- Date initiated
- 2012-12-17
- Date posted
- 2013-03-11
- Date terminated
- 2014-01-14
- Location
- Lansdale, 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 |