FDA Recall
Terminated
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
Recall: Z-0179-05
·
Initiated October 27, 2004
Recall
- Recall Number
- Z-0179-05
- Event Number
- 30330
- Firm
- Cardinal Health 1430 Waukegan Rd Attn V. Mueller Qa McGaw Park IL 60085
- FEI Number
- 3001236905
- Product Code
- FFL
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 27, 2004
- Posted
- November 5, 2004
- Terminated
- December 21, 2004
Description
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
Reason
The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
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.
Distribution
South Carolina, New York, Missouri, West Virginia, Texas and MIssissippi
Quantity
32 units