Recall Z-0486-03 ยท EMX Balloon, Epistaxis
Ultracell Medical Technologies
Rhinocell Nasal 6.0 x 1.5 x 2.0 w/Airway Catalog #: BMPNP601520A
| Date | Jan 30, 2003 (initiated Jan 8, 2003) |
| Status | Terminated |
| Reason | Sterility of the device is compromised |
| Root cause | Other |
| Action | Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts. |
| Quantity | 100 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920358 | ULTRACELL NASAL PACKING Ultracell Medical Technologies, Inc., Nov 30, 1992 |