Recall Z-0487-03 ยท HOZ Sponge, Ophthalmic
Ultracell Medical Technologies
Ultrakleen KSponge II Spears Catalog #: K20-5012
| 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 | 4,047 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923922 | SURGICAL SPEARS Ultracell Medical Technologies, Inc., Mar 19, 1993 |