ClearanceBrief
Recall Z-0489-03 ยท HOZ Sponge, Ophthalmic

Ultracell Medical Technologies

Lasik Spears Blunt (5) Catalog #: U/S32-100

DateJan 30, 2003 (initiated Jan 8, 2003)
StatusTerminated
ReasonSterility of the device is compromised
Root causeOther
ActionUltracell 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.
Quantity126 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K923922SURGICAL SPEARS
Ultracell Medical Technologies, Inc., Mar 19, 1993