ClearanceBrief
Recall Z-0031-05 ยท HBT Applier, Hemostatic Clip

Weck

Hem-o-lok Endo5 Ligation Applier

DateOct 22, 2004 (initiated Aug 18, 2004)
StatusTerminated
ReasonThe jaws may break during clip loading or clip application.
Root causeOther
ActionConsignees were notified via Federal Express (Domestic) and by email (International and Weck Sales Representatives).
Quantity119 units
DistributionNationwide; Australia, Buenos Aires, Canada, France, Korea, New Zealand, Singapore.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.