16 G / 5F Dual Lumen L-Cath catheter only.
FDA device recall Z-0282-06 · posted 2005-12-15 · Terminated
Recall details
- Recalling firm
- Becton Dickinson Medical Systems
- Reason for recall
- Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Action taken
- Consignees were notified via telephone and fax letter, beginning 04/25/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 8090 units
- Distribution
- AL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan.
- Date initiated
- 2005-03-25
- Date posted
- 2005-12-15
- Date terminated
- 2011-08-08
- Location
- Sandy, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| L-CATH PEEL AWAY SYSTEM CATHETER (K920755) | Luther Medical Products, Inc. | 1993-06-07 |