AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
FDA device recall Z-0127-06 · posted 2005-11-05 · Terminated
Recall details
- Recalling firm
- AGA Medical Corporation
- Reason for recall
- Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.
- Action taken
- Urgent Recall letters, dated 09/01/05, were sent to affected customers via email, facsimile and with follow-up delivery via USPS. OUS customers were notified via Federal Express. The letter described the situation, the lots being recalled and included a response form that was to be faxed back to AGA Medical.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRD
- Quantity affected
- 81
- Distribution
- OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom
- Date initiated
- 2005-09-01
- Date posted
- 2005-11-05
- Date terminated
- 2006-11-13
- Location
- Golden Valley, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMPLATZER VASCULAR PLUG (K031810) | Aga Medical Corp. | 2003-09-09 |