ClearanceBrief
Recall Z-1235-03 ยท

Blue Torch Medical Technologies

CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305

DateSep 13, 2003 (initiated Jul 10, 2003)
StatusTerminated
ReasonProduct's sterility is compromised due to a failed sterility audit
Root causeOther
ActionBlue TorchMedical notified 2 consignees by fax on 7/10/03, requesting return of unused inventory.
Quantity20 units
DistributionNY, TX
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K000507CAVERMAP SURGICAL AID
Uromed Corp., Apr 21, 2000
K993436CAVERMAP SURGICAL AID
Uromed Corp., Feb 11, 2000