Recall Z-1133-04 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Braun,B Medical Inc
18G Catheter is a component in various kits.
| Date | Jul 22, 2004 (initiated Apr 16, 2004) |
| Status | Terminated |
| Reason | Catheter separated from the hub. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 also distributed to the following foreign accounts located in Germany, Japan, Puerto Rico, and S |
| FDA record | Open on fda.gov |