Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0418-05

Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6'' 11 French, Rx Only...

Teleflex Medical / initiated 2003-05-21 / Terminated / root cause: packaging

Weck began a recall of Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6'' 11 French, Rx Only, Sterile, Weck A Teleflex Company, Manufactured for... on . The reason FDA records is "Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0418-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
Product
Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6'' 11 French, Rx Only, Sterile, Weck A Teleflex Company, Manufactured for: Weck Closure Systems, 2917 Weck Drive, Research Triangle park, NC 27709, USA.
Product code
GDO Applier, Surgical, Clip
Reason for recall
Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.
Root cause tag
packaging
FDA root cause
Other
Action
Consignees were notified by letter sent via Federal Express on/about 05/21/2003.
Quantity in commerce
667 units
Distribution
Nationwide
Product codes and lots
Catalogue #809600, Lot #978933 & 978934