Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0179-05

V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney...

Medtronic, Inc. / initiated 2004-10-27 / Terminated / root cause: labeling and UDI

Cardinal Health began a recall of V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare... on . The reason FDA records is "The dispenser box was mislabeled with the wrong length and the wrong wire gauge". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0179-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
Product code
FFL Dislodger, Stone, Basket, Ureteral, Metal
Reason for recall
The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Field correction recall by letter dated 10/27/04, nforming the accounts of the mislabeling and providing corrective labels with the correct dimensions to place onto the dispensing box.
Quantity in commerce
32 units
Distribution
South Carolina, New York, Missouri, West Virginia, Texas and MIssissippi
Product codes and lots
product code GU6397, lot number 1041194, exp. 2009/08