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