ClearanceBrief
Recall Z-0479-03 ยท EMX Balloon, Epistaxis

Ultracell Medical Technologies

Ultracell Classic Anatomical Nasal Packing w/Tube (pediatric) Catalog # 10126-CT

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.
Quantity6 boxes
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.