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Terminated

Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.

FDA Recall Z-1024-04 · Posted 2004-07-20

Recalling FirmMedtronic Vascular
Recall StatusTerminated
Product CodeLOX
Date Initiated2004-06-08
Date Terminated2004-11-09
Product Quantity193 units

Reason for Recall

medical device for which sterility may be compromised because of improper seal.

Firm Action

A notice letter was sent to all 40 consignees, and phone contact is made. A physical visit to the account would be conducted to collect affected product.

Root Cause

Other

Distribution Pattern

Product was distributed to 40 hospitals

Official Source

View FDA Recall →

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

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