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
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