Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactu
FDA device recall Z-1029-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Horizon Medical Products Inc
- Reason for recall
- The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
- Action taken
- Consignees were notified via letter on 5/28/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- KOC
- Distribution
- AL, CA, CO, FL, GA, IL, NJ, NY, OH, PA, SC, TN, TX & VA.
- Date initiated
- 2004-05-28
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-12
- Location
- Manchester, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUAL LUMEN CATHETER (DLC) TRAY (K941851) | Neostar Medical Technologies, Inc. | 1995-03-13 |