Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC
FDA device recall Z-0544-06 · posted 2006-03-16 · Terminated
Recall details
- Recalling firm
- Bard Access Systems, Inc
- Reason for recall
- Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.
- Action taken
- Consignees were notified by letter on 12/20/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 743 units
- Distribution
- Nationwide, including VA facilities in CA, FL and IL. No foreign or military distribution.
- Date initiated
- 2005-12-20
- Date posted
- 2006-03-16
- Date terminated
- 2009-08-11
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GROSHONG NXT PICC CATHETERS (K034020) | C.R. Bard, Inc. | 2004-01-21 |
| GROSHONG NXT DUAL LUMEN PICC CATHETERS (K023374) | C.R. Bard, Inc. | 2002-12-18 |