Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0836-05

Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330

Centurion Medical Products, LP / initiated 2005-04-12 / Terminated / root cause: labeling and UDI

Tri-State Hospital Supply Corp began a recall of Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330 on . The reason FDA records is "Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0836-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
Product
Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330.
Product code
HFX Clamp, Circumcision
Reason for recall
Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Consignees were notified to return the product via letter dated 4/12/05.
Quantity in commerce
4078
Distribution
Nationwide.
Product codes and lots
Lots 11224 and 06284.