Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
FDA device recall Z-1024-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Vascular
- Reason for recall
- medical device for which sterility may be compromised because of improper seal.
- Action taken
- 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
- Status
- Terminated
- Product code
- LOX
- Quantity affected
- 193 units
- Distribution
- Product was distributed to 40 hospitals
- Date initiated
- 2004-06-08
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-09
- Location
- Santa Rosa, CA
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