AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.
This recall has been terminated (originally issued November 5, 2005).
- Company
- Aga Medical Corporation
- Recall Initiated
- September 1, 2005
- Posted
- November 5, 2005
- Terminated
- November 13, 2006
- Recall Number
- Z-0127-06
- Quantity
- 81
- Firm Location
- Golden Valley, MN
- Official Source
- View on FDA website ↗
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.
Distribution
OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom
Lot / Code Info
The three lots that were distributed are identified as Lot no. M05F10-11, M05F15-12 and M05F02-47.
Root Cause
Other
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.