18G Catheter is a component in various kits.
FDA device recall Z-1133-04 · posted 2004-07-22 · Terminated
Recall details
- Recalling firm
- Braun,B Medical Inc
- Reason for recall
- Catheter separated from the hub.
- Action taken
- The recalling firm issued a recall notification letter on March 19, 2004 to their direct accounts. The letter identified the problem and instructs the direct account to destroy individual units but return unopened cases to the recalling firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 1176 units
- Distribution
- The units were sent to medical facilities in the following states, as listed: CA, CO, DC, FL, GA, IL, LA, MA, MI, MD, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WI, WV The product was
- Date initiated
- 2004-04-16
- Date posted
- 2004-07-22
- Date terminated
- 2004-09-14
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER (K971085) | B.Braun Medical, Inc. | 1997-06-02 |
| BRAUN PERCUTANEOUS INTRODUCER SET (K961745) | B.Braun Medical, Inc. | 1996-09-17 |