ClearanceBrief
Recall Z-0482-03 ยท KCN Ear Wick

Ultracell Medical Technologies

Ultracell Ear Wick Fenestrated 9mm DIA x 15mm Catalog #: 30305-C

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.
Quantity33 boxes
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K920357ULTRACELL EAR WICK
Ultracell Medical Technologies, Inc., Feb 1, 1993