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Terminated

6F ZUMA EBU4.0 W/110CM LENGTH GUID CATH 6F ZUMA EBU4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6EBU40A, ZM6EBU40A00

FDA Recall Z-1064-06 · Posted 2006-06-01

Recalling FirmMedtronic, Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2006-04-05
Date Terminated2007-06-20
Product Quantity44 units

Reason for Recall

Potential for non-sterility due to loss of package integrity

Firm Action

Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981198MEDTRONIC ZUMA GUIDING CATHETERMedtronics Interventional Vascular · 1998-08-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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