Class 2 Device Recall V. Mueller PfisterSchwartz Stone Retriever

• Date Initiated by Firm: October 27, 2004
• Date Posted: November 05, 2004
• Recall Status: Terminated on December 21, 2004
• Recall Number: Z-0179-05
• Recall Event ID: 30330
• Product Classification: Dislodger, Stone, Basket, Ureteral, Metal - Product Code FFL
• 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
• Code Information: product code GU6397, lot number 1041194, exp. 2009/08
• FEI Number: 3001236905
• Recalling Firm/ Manufacturer: Cardinal Health; 1430 Waukegan Rd; Attn V. Mueller Qa; McGaw Park IL 60085
• For Additional Information Contact: Quality Systems - Professional Services; 800-292-9332
• Manufacturer Reason for Recall: The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.